Molluscum Contagiosum Publications
Molluscum Contagiosum Background
Molluscum Epidemiology and Quality of Life Impact
The Hidden Impact of Molluscum Contagiosum: A Survey of Caregivers’ Experiences with Diagnosis, Treatment, and Impact on Quality of Life. Pearl Kwong MD, PhD1, Adelaide A. Hebert MD2, Collette Utley DNP, NP-C3, Melissa Olivadoti PhD4
Objective: Molluscum contagiosum (molluscum) is considered benign and self-limiting. However, the caregiver and patient experience largely remains a mystery. This online survey aimed to collect caregivers’ views on their experiences with molluscum infection in their children, including diagnosis, treatment, and the impact of the virus on the caregivers’ and their child’s life.
Methods: Parents, caregivers, and/or legal guardians (ages 18+, 20% male and 80% female) of children diagnosed with molluscum in the past 4 years (ages 3-16 years of age) answered a 15-minute paid online survey with questions about their experience with molluscum.
Results: Caregivers (n=150) were mostly Caucasian (85%), 25-44 years of age (87%) and had at least one child with active molluscum (75%) at the time of the survey. The average number of health care providers (HCPs) consulted for molluscum was 1.95 and diagnosis was made by a variety of HCP types. The spread of molluscum to ≥ 1 child in the household was reported by 60% of caregivers in multi-child households. The average number of treatments used were 2.36 including HCP-administered treatments and consumer products. Caregivers reported moderate to major impact on their lives (62%) or their child’s life (74%) due to molluscum.
Limitations: Questions were not validated, recall time was up to 4 years.
Conclusions: Molluscum patients may receive a diagnosis from many sources. Caregivers may utilize more than one treatment modality to help clear the infection including consumer products. Molluscum can cause an impact on quality of life for affected children and their caregivers.
Epidemiology of molluscum contagiosum in children: a systematic review. Olsen JR, Gallacher J, Piguet V, et al. Fam Pract. 2014;31(2):130-136.
- Background. Molluscum contagiosum (MC) is a common skin condition that primarily affects children, a common reason for presenting in primary care and is commonly seen in children presenting with other conditions in primary and secondary care. It is usually asymptomatic but can present with pain, pruritus, erythema and bacterial superinfection.
- Design and setting. A systematic literature review of bibliographical databases on the prevalence, incidence, risk factors, age distribution and association with other conditions for MC in children.
- Results. Data on the epidemiology of MC is largely of poor quality. The largest incidence is in children aged between 0 and 14 years, where the incidence rate ranged from 12 to 14 episodes per 1000 children per year. Incidence rates in the UK were highest in those aged 1–4 years. Meta-analysis suggests a point prevalence in children aged 0–16 years of between 5.1% and 11.5%. There is evidence for an association between swimming and having MC and MC is more common in those with eczema; however, there is little evidence for other risk factors.
- Conclusions. MC is a common condition, with the greatest incidence being in those aged 1–4 years. Swimming and eczema are associated with the presence of MC, but the causal relationships are unclear. There is a lack of data regarding the natural history of MC and published data are insufficient to determine temporal or geographic patterns in incidence, risk factors, duration of symptoms or transmission between family members.
- Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: A prospective community cohort study. Olsen JR, Gallacher J, Finlay AY, et al. Lancet Infect Dis. 2015;15(2):190-195.
- Molluscum contagiosum is one of the 50 most prevalent diseases worldwide, but scarce epidemiological data exist for childhood molluscum contagiosum. We aimed to describe the time to resolution, transmission to household child contacts, and effect on quality of life of molluscum contagiosum in children in the UK. Between Jan 1, and Oct 31, 2013, we recruited 306 children with molluscum contagiosum aged between 4 and 15 years in the UK either by referral by general practitioner or self-referral (with diagnosis made by parents by use of the validated Molluscum Contagiosum Diagnostic Tool for Parents [MCDTP]). All participants were asked to complete a questionnaire at recruitment about participant characteristics, transmission, and quality of life. We measured quality of life with the Children’s Dermatology Life Quality Index (CDLQI). Participants were prospectively followed up every month to check on their recovery from molluscum contagiosum and transmission to other children in the same household, until the child’s lesions were no longer visible. The mean time to resolution was 13·3 months (SD 8·2). 80 (30%) of 269 cases had not resolved by 18 months; 36 (13%) had not resolved by 24 months. We recorded transmission to other children in the household in 102 (41%) of 250 cases. Molluscum contagiosum had a small effect on quality of life for most participants, although 33 (11%) of 301 participants had a very severe effect on quality of life (CDLQI score >13). A greater number of lesions was associated with a greater effect on quality of life (H=55·8, p<0·0001). One in ten children with molluscum contagiosum is likely to have a substantial effect on their quality of life and therefore treatment should be considered for some children, especially those with many lesions or who have been identified as having a severe effect on quality of life. Patients with molluscum contagiosum and their parents need to be given accurate information about the expected natural history of the disorder. Our data provide the most reliable estimates of the expected time to resolution so far and can be used to help set realistic expectations.
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The Hidden Impact of Molluscum Contagiosum: Survey of Caregivers’ Experiences with Diagnosis and Management Pearl Kwong, Adelaide Hebert, Collette Utley, Melissa Olivadoti Maui Derm Connect Dermatology Congress (Virtual) September 23-27, 2020
Objective: Molluscum contagiosum (molluscum) is a common pediatric viral skin infection. While this condition is considered benign and self-limiting, molluscum can last for months to years and cause itching and pain. The experience in caring for a child with molluscum largely remains a mystery, with few studies published on the topic. This online survey aimed to collect caregivers’ views on their experiences with molluscum infection in their children.
Methods: Parents, caregivers, and/or legal guardians of children (ages 3-16 years) who were diagnosed with molluscum in the past 4 years were recruited to answer a 15-minute paid online survey. Margin of error at the 95% confidence interval for the total sample was ± 7.7%. Survey questions inquired about the type of health care provider (HCP) consulted, diagnosis, treatment, and how severely molluscum impacted the caregiver and the child.
Results: Respondents (n=150) were mostly Caucasian (85%), 25-44 years of age (87%), and had at least one child with an active infection (75%). Median household size was 4 people. The median age of children in the home was 8 years. Most respondents saw at least 2 types of HCPs for their child’s molluscum. Diagnosis was completed by Pediatrics (49%), Family Practice (37%), Dermatology (34%), Infectious Disease (23%), and/or Emergency Room (21%). Spread of molluscum to ≥ 1 child in the household was reported in 60% of caregivers. Most caregivers were offered treatment options by the health care provider (61%) vs. allowing the disease to remit on its own (39%). Most caregivers reported moderate to major impact on their lives (62%), 70% agreed with the statement that molluscum kept their child away from doing things they love, and 62% agreed they worried what others thought of their child having molluscum. Many respondents (47%) considered squeezing or removing lesions themselves at home and 31% utilized this strategy. The most common approaches to treatment were home remedies (43%) and molluscum treatments purchased from Amazon.com or a drug store with no Rx required (41%), followed by cryosurgery (41%), cantharidin (39%), and curettage (31%). The average number of treatments used was 2.36.
Conclusions: Results indicate that molluscum patients receive diagnoses from many HCP types, often visiting more than one HCP. Many patients do not receive treatment, and those that do receive treatment are likely to use more than one modality in attempt to clear the infection. Caregivers were likely to attempt to try at-home remedies or use unproven/unapproved remedies, as well as attempt to disrupt lesions themselves, creating opportunities for autoinoculation and spread of the infection. Not surprisingly, spread to another child in the household was common. Finally, a moderate to high impact on quality of life for caregivers and an impact on activities for their children with molluscum was reported. This suggests that while physically benign, molluscum has an emotional impact patients and their caregivers, with concern over a negative social stigma.
Funding Statement: Funding for this survey was provided by Verrica Pharmaceuticals Inc., in conjunction with Whitman Insight Strategies.
- Infectious Diseases Associated With Organized Sports and Outbreak Control. Davies HD, Jackson, MA, and Rice SG. Pediatrics. 2017;140(4):e20172477.
- Participation in organized sports has a variety of health benefits but also has the potential to expose the athlete to a variety of infectious diseases, some of which may produce outbreaks. Major risk factors for infection include skin-to-skin contact with athletes who have active skin infections, environmental exposures and physical trauma, and sharing of equipment and contact with contaminated fomites. Close contact that is intrinsic to team sports and psychosocial factors associated with adolescence are additional risks. Minimizing risk requires leadership by the organized sports community (including the athlete’s primary care provider) and depends on outlining key hygiene behaviors, recognition, diagnosis, and treatment of common sports related infections, and the implementation of preventive interventions.
- Molluscum contagiosum virus infection: Chen X, Anstey AV and Bugert JJ. Lancet Infect Dis. 2013; 13(10):877-888.
- Molluscum contagiosum virus is an important human skin pathogen: it can cause disfigurement and suffering in children, in adults it is less common and often sexually transmitted. Extensive and persistent skin infection with the virus can indicate underlying immunodeficiency. Traditional ablative therapies have not been compared directly with newer immune-modulating and specific antiviral therapies. Advances in research raise the prospect of new approaches to treatment informed by the biology of the virus; in human skin, the infection is localized in the epidermal layers, where it induces a typical, complex hyperproliferative lesion with an abundance of virus particles but a conspicuous absence of immune effectors. Functional studies of the viral genome have revealed effects on cellular pathways involved in the cell cycle, innate immunity, inflammation, and cell death. Extensive lesions caused by molluscum contagiosum can occur in patients with DOCK8 deficiency-a genetic disorder affecting migration of dendritic and specialized T cells in skin. Sudden disappearance of lesions is the consequence of a vigorous immune response in healthy people. Further study of the unique features of infection with molluscum contagiosum virus could give fundamental insight into the nature of skin immunity.
- Pathogenesis of Molluscum Contagiosum: A new concept for the spontaneous involution of the disease. Sharquie KE, Hameed AF and Abdulwahhab, WS. 2015. Our Dermatology Online.10.72421.
- Background: Molluscum contagiosum is a common viral skin disease that usually has a self-clearing course.
- Objectives: to study the process of involution of molluscum contagiosum through utilizing histological examination.
- Patients and Methods: Different sizes and stages of evolution of lesions from 50 patients with molluscum contagiosum were included. Deep shave biopsies were taken from each patient for histopathological examination.
- Results: All lesions showed a single punctum and this was confirmed by histopathological examination. Each individual lesion showed an epidermal hyperplasia consisting of many lobes which subdivided into lobules that contain the molluscum bodies. The intra-cytoplasmic molluscum inclusion bodies increase in the number and size as the cells differentiate toward the surface of the epidermis to accumulate at a central meeting point equivalent to the clinical sign of umblication at which the infected cells undergo cytocidal disintegration releasing its viral contents into the skin surface. The general histological architecture resemble that of keratoacanthoma. Conclusion: The central umblication represent the site of the future involution that contains the final growth phase of the infected epidermal cells where it ends by a process of cellular death and disintegration releasing its viral contents into the surface of the skin at the craterform opening which is called punctum. This process of self-involution may resemble that of keratoacanthoma where there are many similar pathological features in both conditions.
Association Between Molluscum Contagiosum and Atopic Dermatitis
- Molluscum contagiosum virus infection can trigger atopic dermatitis disease onset or flare. Silverberg NB. Cutis. 2018;102(3):191-194.
- Predisposition to cutaneous viral infections is known to be a minor criterion of Hanifin and Rajka’s diagnostic standard of atopic dermatitis (AD); however, the causal relationship between molluscum contagiosum virus (MCV) infection and AD onset or aggravation has not been widely explored. The objective of this study was to identify pediatric patients with AD onset or flare triggered by MCV infection as well as to characterize the setting under which MCV may trigger AD onset or flares in children. Fifty children with prior or current MCV infection presenting sequentially to an outpatient pediatric dermatology practice over a 1-month period were evaluated. Results indicated that children who contract MCV infection may be targets for skin care interventions to prevent and/or control AD.
- Molluscum contagiosum and associations with atopic eczema in children: a retrospective longitudinal study in primary care. Olsen JR, Piguet V, Gallacher J, et al. Br J Gen Pract. 2016;66(642):e53-e58.
- Background: Molluscum contagiosum (MC) is a common skin condition in children. Consultation rates and current management in primary care, and how these have changed over time, are poorly described. An association between the presence of atopic eczema (AE) and MC has been shown, but the subsequent risk of developing MC in children with a diagnosis of AE is not known.
- Aim: To describe the consultation rate and management of MC in general practice in the UK over time, and test the hypothesis that a history of AE increases the risk of developing MC in childhood.
- Design and setting: Two studies are reported: a retrospective longitudinal study of MC cases and an age–sex matched case-cohort study of AE cases, both datasets being held in the UK Clinical Practice Research Datalink from 2004 to 2013.
- Method: Data of all recorded MC and AE primary care consultations for children aged 0 to 14 years were collected and two main analyses were conducted using these data: a retrospective longitudinal analysis and an age–sex matched case-cohort analysis.
- Results: The rate of MC consultations in primary care for children aged 0 to 14 years is 9.5 per 1000 (95% CI = 9.4 to 9.6). The greatest rate of consultations for both sexes is in children aged 1–4 years and 5–9 years (13.1 to 13.0 (males) and 13.0 to 13.9 (females) per 1000 respectively). Consultation rates for MC have declined by 50% from 2004 to 2013. Children were found to be more likely to have an MC consultation if they had previously consulted a GP with AE (OR 1.13; 95% CI = 1.11 to 1.16; P<0.005).
- Conclusion: Consultations for MC in primary care are common, especially in 1–9-year-olds, but they declined significantly during the decade under study. A primary care diagnosis of AE is associated with an increased risk of a subsequent primary care diagnosis of MC.
Current Management for Molluscum Contagiosum
Current Treatment Practices for Molluscum Contagiosum
- A Prospective Randomized Trial Comparing the Efficacy and Adverse Effects of Four Recognized Treatments of Molluscum Contagiosum in Children. Hanna D, Hatami A, Powell J, et al. Pediatr Dermatol. 2006;23(6):574-579.
- Abstract: Molluscum contagiosum is a common viral disease of childhood presenting as small, firm, dome-shaped umbilicated papules. Although benign and generally self-limited, this condition is contagious and can lead to complications such as inflammation, pruritus, dermatitis, bacterial superinfection, and scars. No consensus has been established concerning the management of this condition. We conducted a prospective randomized study comparing four common treatments for molluscum contagiosum in 124 children aged 1 to 18 years. One group was treated with curettage, a second with cantharidin, a third with a combination of salicylic acid and lactic acid, and a fourth with imiquimod. Patients needing, respectively, one, two, or three visits for treatment of their mollusca were: 80.6%, 16.1%, and 3.2% for curettage, 36.7%, 43.3%, and 20.0% for cantharidin, 53.6%, 46.4%, and 0% for salicylic acid and glycolic acid, and 55.2%, 41.4%, and 3.4% for imiquimod. The rate of side effects was 4.7% for group 1, 18.6% for group 2, 53.5% for group 3, and 23.3% for group 4. Curettage was found to be the most efficacious treatment and had the lowest rate of side effects. It must be performed with adequate anesthesia and is a time-consuming procedure. Cantharidin is a useful bloodless alternative particularly in the office setting but has moderate complications due to blisters and necessitated more visits in our experience. The topical keratolytic used was too irritating for children. Topical imiquimod holds promise but the optimum treatment schedule has yet to be determined. Finally, we believe that the ideal treatment for mollusca depends on the individual patient preference, fear, and financial status, distance from the office, and whether they have dermatitis or blood-borne infections.
- Molluscum contagiosum: the importance of early diagnosis and treatment. Tyring SK. Am J Obstet Gynecol. 2003;189(3 Suppl):S12-S16.
- Molluscum contagiosum is a viral infection that is becoming an increasing problem in sexually active individuals and in patients with human immunodeficiency virus. Although molluscum contagiosum lesions are generally self-limiting, it may take 6 months to 5 years for lesions to disappear. Furthermore, patients with weakened immune systems have increased difficulty in clearing lesions; therefore lesions typically persist for prolonged periods. Although there has been continued debate about whether molluscum contagiosum lesions should be treated or allowed to resolve spontaneously, many clinicians recommend treatment of genital molluscum contagiosum lesions to reduce the risk of sexual transmission, prevent autoinoculation, and increase patient quality of life. Treatment options for molluscum contagiosum include physician-administered and patient-administered therapies. Novel patient-administered treatment options allow administration in the privacy of a patient’s home, providing added convenience and reducing patient embarrassment or stress. With the novel treatment opportunities currently available or in development, physicians are able to improve patient quality of life while providing patients with a convenient, well-tolerated, easily administered treatment regimen. This review summarizes the clinical diagnosis of molluscum contagiosum and provides a critical assessment of several current and emerging treatment options.
Cantharidin Mechanism of Action
- The Mechanism of Cantharidin Acantholysis. Weakley DR, Eindinder, JM. The Journal of Investigative Dermatology. 35-41.
- In an earlier paper, we reviewed the literature concerning cantharidin acantholysis and commented on the theories thus far proposed to explain its production. New data were presented, and it was concluded that no adequate biochemical explanation currently exists. Stoughton first emphasized that cantharidin probably acts by affecting some enzyme or enzyme system, and substantiated his theory by producing acantholysis with intradermal injections of papain as well as a proteolytic enzyme isolated from sterile feces of patients with ulcerative colitis. He also pointed out, however, that cantharidin acantholysis showed histologic differences from that produced by these enzymes. Further, he was unable to demonstrate the reaction products expected if such enzymes do indeed mediate the action of cantharidin on skin. The independent development in two laboratories of a dilute aqueous solution of disodium cantharidin (DSC) which readily produces both acantholysis and intraepidermal vesication in vitro has facilitated investigation of the specific biochemical lesion it causes. Many recent data indicate that a number of dermatologic diseases are probably manifestations of specific metabolic aberrations in the skin. Since the cantharidin-skin system used in the experiments reported here works equally well with human or mouse skin, it provided an unusual opportunity to perform biochemical studies on a model system producing acantholysis. Because of the close similarity between the histologic changes induced by cantharidin and those of pemphigus vulgaris, further investigation seemed warranted. The results of these experiments indicate that cantharidin acantholysis is closely linked to the oxidative metabolism of carbohydrate.
- Cantharide acantholysis: endogenous protease activation leading to desmosomal plaque dissolution. Bertaux B, Prost C, Heslan M, et al. Br J Dermatol. 1988;118(2):157-165.
- Using a method which allowed us to study the morphological consequences of the expression and the inhibition of proteases in living tissues, we demonstrated that the primary detectable cellular event in cantharide acantholysis is the dissolution of the dense plaque, leading to the detachment of tonofilaments from desmosomes. This process is inhibited by neutral serine protease inhibitors. This suggests that the desmosome-tonofilament complex, more precisely the desmosomal dense plaque, is the primary target of activated proteases during cantharide acantholysis, and can be disrupted by a specific epidermal protease-anti protease system. Cantharide acantholysis may be useful model for studying desmosomal turnover.
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- Cantharidin-Induced Acantholysis. Piérard-Franchimont C, Piérard GE. The American Journal of Dermatopathology. 1988 (Oct)419-423.
- Cantharidin has been used to induce acantholysis in vivo. Intraepidermal clefting starts at the junction between the basal and epidermal layers, and later involves all of the levels of the stratum spinosum. As a response to early acantholysis, an increased number of epibasal cells synthesize DNA. This is not related to an increased binding of epidermal growth factor to these cells. In sum, the basal-epibasal junction is one of the weakest within the epidermis. The epibasal cells represent a reserve pool for proliferating keratinocytes that may be stimulated without necessarily binding an increased amount of epidermal growth factor.
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- Cantharidin-induced acantholysis: adhesion molecules, proteases, and related proteins. Yell JA, Burge SM, Dean D. British Journal of Dermatology. 130: 148-157.
- Summary: Acantholysis is a feature of disorders such as Hailey‐Hailey disease and Darier’s disease. Immunocytochemical studies have shown internalization of desmosomal components after acantholysis. Basal cytokeratins show suprabasal expression in lesional Darier’s disease. The exact mechanisms of acantholysis are still unclear. Cantharidin induces blistering, with suprabasal keratinocyte acantholysis, possibly by protease activation. Plasmin has been implicated in the pathogenesis of acantholysis in Darier’s disease and Hailey‐Hailey disease. We examined the distribution of desmosomal components, proteases and cytokeratins in cantharidin blisters, to compare them with those previously found in Darier’s disease and Hailey‐Hailey disease. Two drops of cantharidin collodion were applied to the skin of five normal volunteers. A 4‐mm punch biopsy of the blister was taken, and snap frozen. Sections were stained with antibodies to desmosomal proteins (dp) 1/2, dp 3, desmosomal glycoproteins (dg) 1, 2/3, extracellular carbohydrate residues, using the lectins peanut agglutinin (PNA) and soybean agglutinin (SBA), proteases and cytokeratins. Acantholytic cells were stained diffusely with dp l/2: there was markedly reduced or absent peripheral staining for dp 3, dg l, dg 2/3, PNA and SBA. There was no clumping of stain. Plasminogen, fibrinogen and urokinase were expressed in some acantholytic cells. Basal keratin markers were expressed suprabasally in acantholytic cells. These results are similar to those previously obtained in Darier’s disease, but different from the staining obtained in Hailey‐Hailey disease. Extracellular glycosylated portions of adhesion molecules may be lost after acantholysis, perhaps as a result of conformational changes, internalization of extracellular domains, or proteolysis. The changes in the expression of plasminogen, fibrinogen, urokinase and cytokeratins in acantholytic cells in cantharidin‐induced blisters are, as in Darier’s disease and Hailey‐Hailey disease, probably secondary to acantholysis, and changes in the shape of cells. We conclude that cantharidin blisters may be a useful model for the study of acantholysis in Darier’s disease.
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- Cantharidin blisters: a technique for investigating leukocyte trafficking and cytokine production at sites of inflammation in humans. Day RM, Harbord M, Forbes A, et al. J Immunol Methods. 2001; 257(1-2):213-220.
- A skin blister technique is described which allows the investigation of acute inflammation in humans in vivo. Filter paper discs are placed on the skin, impregnated with cantharidin and covered with impermeable film held by adhesive tape. The assembly is easily applied, unobtrusive, stable and may be worn during normal activities. The blister formed at 24 h contains approximately 5×10(5)-5×10(6) cells, predominantly neutrophils and macrophages. Inflammatory cytokines and chemotactic factors are detectable in the blister fluid. The technique is useful for characterizing the acute inflammatory response in health and disease.
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- Production and resolution of cantharidin-induced inflammatory blisters. Maglio D, Nightingale CH, Nicolau DP. International journal of antimicrobial agents. 2003; 22. 77-80.
- While inflammatory blisters have long been utilized as a means of evaluating antimicrobial disposition to aid in the development of new treatments for skin and skin structure infections, sparse data are available regarding the healing of the blisters once the experiment has been completed. We report the blister induction technique and resolution time in ten volunteers enrolled in a pharmacokinetic study using the cantharidin-induced inflammatory blister technique.
- Paid access.
- Characterisation of Leukocytes in a Human Skin Blister Model of Acute Inflammation and Resolution. Jenner W, Motwani M, Veighey K, et al. PLOS ONE. 2014; 9(3): e89375.
- There is an increasing need to understand the leukocytes and soluble mediators that drive acute inflammation and bring about its resolution in humans. We therefore carried out an extensive characterisation of the cantharidin skin blister model in healthy male volunteers. A novel fluorescence staining protocol was designed and implemented, which facilitated the identification of cell populations by flow cytometry. We observed that at the onset phase, 24 h after blister formation, the predominant cells were CD16hi/CD66b+ PMNs followed by HLA-DR+/CD14+ monocytes/macrophages, CD11c+ and CD141+ dendritic cells as well as Siglec-8+ eosinophils. CD3+ T cells, CD19+ B cells and CD56+ NK cells were also present, but in comparatively fewer numbers. During resolution, 72 h following blister induction, numbers of PMNs declined whilst the numbers of monocyte/macrophages remain unchanged, though they upregulated expression of CD16 and CD163. In contrast, the overall numbers of dendritic cells and Siglec-8+ eosinophils increased. Post hoc analysis of these data revealed that of the inflammatory cytokines measured, TNF-α but not IL-1β or IL-8 correlated with increased PMN numbers at the onset. Volunteers with the greatest PMN infiltration at onset displayed the fastest clearance rates for these cells at resolution. Collectively, these data provide insight into the cells that occupy acute resolving blister in humans, the soluble mediators that may control their influx as well as the phenotype of mononuclear phagocytes that predominate the resolution phase. Further use of this model will improve our understanding of the evolution and resolution of inflammation in humans, how defects in these over-lapping pathways may contribute to the variability in disease longevity/chronicity, and lends itself to the screen of putative anti-inflammatory or pro-resolution therapies.
Compounded Cantharidin for the Treatment of Molluscum Contagiosum
- Topical Cantharidin in the Management of Molluscum Contagiosum: Preliminary Assessment of an Ether-free, Pharmaceutical-grade Formulation. Del Rosso JQ, Kircik L. J Clin Aesthet Dermatol. 2019;12(2):27-30.
- Topical application of cantharidin, a vesicant that is naturally derived from the blister beetle, has a long track record of being used to treat primarily cutaneous molluscum contagiosum and Verrucae. Although not approved by the United States Food and Drug Administration, cantharidin has been available through a variety of compounding sources without standardization of manufacturing, formulation, or method of application. Randomized, controlled studies assessing safety and efficacy of topical cantharidin are limited, to date, with the majority of published evidence gleaned from collective clinical experience. A recent Phase II pilot study evaluating a specific formulation of cantharidin 0.7% solution [w/v] (VP-102) has demonstrated promising efficacy and safety results, with additional studies forthcoming, including the designated use of a patented application device that contains the solution.
- Beetle juice: a guide for the use of cantharidin in the treatment of molluscum contagiosum. Moye V, Cathcart S, Burkhart CN, et al. Dermatol Ther. 2013;26(6):445-451.
- Molluscum contagiosum (MC) is an increasingly common cutaneous viral infection that primarily affects the pediatric population. MC lesions are benign, and most cases resolve within 6–9 months. Nonetheless, many patients and their parents seek active treatment of MC because of local pain, pruritus, embarrassment due to the lesions, or desire to reduce transmission to siblings. Individuals with atopic dermatitis are predisposed to severe and protracted MC, and immunocompromised patients may never clear the infection without treatment. Despite the availability of various therapies, no clear best treatment for MC has emerged. Cantharidin is a commonly used and effective therapy for MC that is generally well tolerated and has high rates of parental satisfaction. In this review, current literature regarding MC is summarized and particular focus is placed on the use of cantharidin for treating MC, including a review of the literature and detailed instructions for its use.
- Paid access.
- Safety of cantharidin: a retrospective review of cantharidin treatment in 405 children with molluscum contagiosum. Moye VA, Cathcart S, Morrell DS. Pediatr Dermatol. 2014;31(4):450-454.
- Cantharidin is a widely used treatment for molluscum contagiosum (MC) that is often favored because of its speed of application and lack of pain at the time of application. Previous studies have supported its safety and reported high parental and dermatologist satisfaction with its use. Nonetheless, a lack of safety data has contributed to ambiguous U.S. Food and Drug Administration status that has made it increasingly difficult to obtain. All children treated with cantharidin for MC at a tertiary care center between January 1, 2005, and December 31, 2011, who had at least one follow-up visit or telephone call were included in the current study. Information related to treatment with cantharidin and adverse effects was abstracted from medical records. Of 512 children identified, 405 had at least one follow-up visit or telephone call after treatment and were included in this study. Cantharidin was applied to 9,688 lesions over 1,056 visits. Fifty-seven percent of children experienced blistering, an expected effect of therapy. Eleven percent of patients experienced adverse events. The most common adverse events were pain (7%) and significant blistering (2.5%). Other side effects were rare (<1%) and included pruritus, possible mild infection, significant irritation, id reactions, and bleeding. Eighty-six percent of parents reported satisfaction with cantharidin or opted to use it again. Cantharidin is a safe treatment modality for MC and should be considered when symptomatic infection necessitates treatment. The cantharidin application protocol used in this study may serve as a model protocol with a known side-effect profile.
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- Compounding in Dermatology Update. Agnetta V, Torres A, Desai S, et al. Journal of Drugs in Dermatology. 2020;19(2) :s18.
- Medication compounding is defined as any alteration, mixing, or combining of two or more ingredients that make the drug more specific to the needs of the patient. Compounded medications are used widely in patient care to meet their individual medical needs and maximize treatment outcomes. The Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have been the leading organizations in creating the official rules and guidelines of drug compounding.
- Ever since an outbreak of fungal meningitis in 2012 from contaminated steroid injections causing multiple deaths, safety in medication compounding has been a major source of concern resulting in a series of new compounding rules, regulations and guidelines set by the regulating agencies. These new standards were developed with the intention to maximize medication safety. Between 2012 and today, there have been multiple revisions and changes to the rules reflecting a very complex and dynamic issue on medication compounding.
- While patient safety should and has always been the primary focus of the health providers, the FDA, and the USP, these strict and constantly changing complex rules pose many challenges to health practitioners when planning the treatment plan for their patients. Limitations to compounding particular medication mixtures can restrict treatment options leaving patients and providers with few or no good treatment alternatives and ultimately negatively affecting patient care.
Use of VP-102 for Molluscum Contagiosum*
- Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. Eichenfield LF, McFalda W, Brabec B, et al. JAMA Dermatol. doi:10.1001/jamadermatol.2020.3238
- Importance: Molluscum contagiosum (MC) is a common viral skin infection that primarily affects children. Cantharidin, a topical vesicant, has a long history of use for MC in compounded formulations, but the safety and efficacy of doses, regimens, and application methods have not been demonstrated in large-scale trials.
- Objective: To determine the safety and efficacy of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), compared with vehicle in individuals with MC.
- Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials of identical design (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) were conducted in 31 centers across the US. A total of 528 individuals aged 2 years or older with MC participated. CAMP-1 was conducted from March 21 to November 26, 2018, and CAMP-2 was conducted from February 14 to September 26, 2018.
- Interventions: Participants were randomized (3:2) to topical application of VP-102 or vehicle to all treatable lesions every 21 days until complete lesion clearance or up to 4 treatments.
- Main Outcomes and Measures: The primary efficacy outcome was the proportion of VP-102–treated participants achieving complete clearance of all MC lesions (baseline and new) compared with those who received the vehicle at the end-of-study visit on day 84. Intent-to-treat analysis was conducted for the efficacy population. Secondary efficacy outcomes included the proportion of participants achieving complete clearance of lesions at days 21, 42, and 63. Safety outcomes included assessment of adverse events, including expected local skin reactions.
- Results: Of the 528 participants enrolled, 527 received treatment (CAMP-1, n = 265; CAMP-2, n = 262). A total of 267 of 527 participants (50.7%) were male; mean (SD) ages for CAMP-1 and CAMP-2 were 7.5 (5.3) years and 7.4 (8.0) years for the VP-102 groups and 6.3 (4.7) years and 7.3 (6.7) years for the vehicle groups. Treatment with VP-102 demonstrated superior efficacy to vehicle in the percentage of participants with complete clearance of MC lesions at the end of the study visit for CAMP-1 (VP-102: 46.3% vs vehicle: 17.9%; P < .001) and CAMP-2 (VP-102: 54.0% vs vehicle: 13.4%; P < .001). Adverse events were observed in 99% (CAMP-1) and 95% (CAMP-2) of VP-102–treated participants and 73% (CAMP-1) and 66% (CAMP-2) of vehicle-treated participants. The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab. Most adverse events were mild or moderate in severity.
- Conclusions and Relevance: In the 2 phase 3 trials reported herein, VP-102 was statistically significantly superior to vehicle in achieving complete clearance of MC lesions at the end of the study visit in both trials, with adverse events that were generally mild to moderate and confined to application sites. These findings show that VP-102 is potentially an effective and safe treatment for MC, a common skin condition with no US Food and Drug Administration–approved treatments.
- Trial Registrations: ClinicalTrials.gov Identifiers: NCT03377790 and NCT03377803
- A Phase 2 Open-Label Study to Evaluate VP-102 for the Treatment of Molluscum Contagiosum. Niazi S, Brabec B, Anschutz L, et al. Journal of Drugs in Dermatol 2021 ; 20(1)
- Background: This Phase 2, open-label study evaluated the safety, efficacy, systemic exposure, and impact on quality of life (QoL) with treatment using VP-102, a drug-device combination containing cantharidin (0.7% w/v) in subjects with molluscum contagiosum (MC).
- Study Design: Pediatric subjects with MC (2–15 years of age) were eligible to enroll in this 12-week study. MC lesions were treated topically with VP-102 every 21 days until clearance (maximum of 4 treatments). Adverse events (AEs) and QoL outcomes (using the Children’s Quality of Life Index, CDLQI) were documented at each visit. Rate of complete clearance and the percent reduction in lesions were measured at each visit on days 21, 42, 63, and 84 (end of study [EOS] visit). A group of 17 subjects with at least 21 MC lesions was evaluated for systemic cantharidin exposure via plasma samples obtained before the first application of VP-102, and at 2 hours, 6 hours, and 24 hours post-application.
- Results: A total of 33 subjects enrolled in the study (n=17 systemic exposure group, n=16 standard group). There were an equal number of male and female subjects. Subject mean (SD, range) age was 6.7 (3.3, 2–15) years, with a mean lesion count of 30 (26.1, 3–113). Complete lesion clearance was achieved in 48.5% of subjects, with a 90.4% reduction in lesions from baseline to the EOS visit. Mean CDLQI score decreased from 2.6 at baseline to 0.38 at the EOS visit. AEs were mild to moderate in severity and expected due to the pharmacodynamic action of cantharidin. There were no serious treatment-related adverse events and no study discontinuations due to treatment. In the systemic exposure group plasma cantharidin levels were below the lower limit of quantitation (LLOQ, 2.5 ng/ mL) in 65 of 66 samples.
- Conclusions: VP-102 treatment resulted in a reduction in lesion counts and improved QoL. Treated subjects had a 48.5% rate of complete clearance of molluscum lesions. Negligible systemic cantharidin exposure was observed in the systemic exposure group. This data demonstrates safety and efficacy of treatment with VP-102 in MC; a widespread viral infection that does not have any current FDA-approved treatments.
- Significant Finding: Treatment of subjects with MC using VP-102 resulted in negligible systemic cantharidin exposure, as well as a reduction in lesion counts, improved QoL, and a demonstrated efficacy in clearance of new and baseline MC lesions.
- Meaning: Results of this Phase 2 study demonstrate efficacy and safety outcomes in using VP-102 in MC subjects, and large randomized clinical trials are warranted to compare topical VP-102 with a vehicle control in order to fully evaluate the use of the medication.
- Pooled Results of Two Randomized Phase III Trials Evaluating VP‑102, a Drug‑Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Eichenfield L.F., Siegfried E., Kwong P., et al. Amer J Clin Derm 2021; 22(2), 257-265
- Background: Compounded cantharidin has been used for decades to treat molluscum contagiosum but lacks rigorous clinical evidence to support its safety and efficacy. VP-102 is a shelf-stable drug–device combination product that contains topical cantharidin (0.7% weight/volume [w/v]) and is being evaluated for the treatment of molluscum.
- Objectives: Our objective was to present pooled safety and efficacy analyses of VP-102 in the treatment of molluscum compared with vehicle.
- Methods: Participants aged ≥ 2 years were randomized 3:2 to topical administration of VP-102 or vehicle in two randomized, double-blind, vehicle-controlled phase III trials. Study drug was applied to all baseline and new lesions once every 21 days until clear or for a maximum of four applications. Assessors blinded to treatment counted all lesions at each study visit. All adverse events (AEs) were documented. Data were pooled for analyses.
- Results: In total, 310 participants received VP-102 and 218 received vehicle. Mean age was 7.5 years (range 2–60) for VP-102 and 6.8 (2–54) for vehicle. Complete clearance of all molluscum lesions at day 84 occurred in 50% of VP-102 participants and 15.6% of vehicle recipients (p < 0.0001). Mean molluscum lesion counts decreased 76% for VP-102 and 0.3% for vehicle at day 84 (p < 0.0001). The most common AEs in the VP-102 group were application site blistering, pruritus, pain, and erythema, which were generally mild or moderate in severity.
- Conclusions: Pooled analyses showed a significantly higher percentage of participants with complete molluscum lesion clearance and larger reductions in lesion counts with VP-102 than with vehicle. AEs were anticipated because of the pharmacodynamic properties of cantharidin.
- CAMP (Cantharidin Application in Molluscum Patients)-1 and CAMP-2: Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Pivotal Studies Investigating VP-102, a Drug-device Combination Containing a Novel Topical Formulation of Cantharidin for the Treatment of Molluscum Contagiosum. Eichenfield LF, McFalda W, Brabec B, et al. Integrative Dermatology Symposium, October 2019.
- Background: Cantharidin is a topical vesicant, derived from blister beetles, routinely used to treat molluscum contagiosum. Cantharidin is not FDA approved and lacks robust clinical evidence supporting for safety and efficacy in in MC.
- Methods: Two randomized, double-blind, vehicle-controlled Phase-3 trials included subjects ≥ 2 years of age randomized 3:2 to VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or up to 4 applications. Blinded assessors counted all lesions at each clinic visit as well as the end of study (EOS) visit (D84). Adverse event (AE) occurrence and severity were documented throughout the study, with a specific focus on local site reactions.
- Results: Both trials showed similar baseline demographics, MC characteristics, and diagnostic history. Mean age was 7.5 and 7.4 for VP-102 (n=260 and n=112 for CAMP-1 and CAMP-2; range 2-60) and 6.3 and 7.3 for vehicle (n=106 and n=112; range 2-54). Complete clearance of all lesions occurred in 46% and 54% of VP-102 subjects at the EOS vs. 18% and 13% for vehicle (p <0.0001 for each trial). Significant differences in complete clearance were seen between groups as early as the second treatment visit (Day 42) (p<0.05, respectively). VP-102 was well-tolerated in both trials as evidenced by low discontinuation rates due to AEs (3% and 0.7% in VP-102 groups). Most common AE’s included application site blistering, pruritus, pain, and erythema, all of which were anticipated with VP-102. 91% and 89% of patients in the VP-102 groups experienced blistering at 24 hours after the first treatment for CAMP-1 and 2. 93% and 99% of VP-102 patients who experienced blistering reported them as smaller than a dime in size at that time point.
- Conclusions: Treatment with VP-102 was well-tolerated. Complete clearance rates were significantly improved with VP-102 compared to vehicle as early as the second treatment visit, continuing to the EOS visit.
- ≥75% and ≥90% clearance rates for treated lesions in CAMP-1 and CAMP-2: Pooled results of two identical, Phase III randomized, vehicle- controlled studies with a novel drug-delivery combination formulation of 0.7% cantharidin (w/v; VP-102) for the topical treatment of molluscum contagiosum. Eichenfield LF, McFalda W, Brabec B, et al. Fall Clinical Dermatology Symposium, October 2019.
- Background: Two identical, multicenter, randomized, double-blind, vehicle-controlled, trials (RCTs) with a standardized, pharmaceutical grade formulation of cantharidin (0.7% w/v) in a drug-device (VP-102) were conducted to test the safety and efficacy in subjects with molluscum contagiosum (MC). Exploratory objectives included the time course and percentage of subjects with ≥75% and ≥90% lesion clearance rates in the intent-to-treat population.
- Methods: Qualified subjects ≥2 years old were enrolled in two RCTs and were randomized 3:2 to VP-102 or vehicle, applied to all baseline and new lesions once every 21 days until clear, or up to 4 applications. Subjects were instructed to remove VP-102 or vehicle 24 hours after application. Assessors blinded to treatment counted all lesions at Days 21, 42, 63 and 84 (the end of study visit; EOS). Adverse events (AEs) were documented throughout study with a specific focus on local site reactions.
- Results: Total subjects in the ITT population included 310 for VP-102 and 218 for vehicle. Median age was 6 years (range 2-60) for both groups, median time since clinical diagnosis was 26 days for VP-102 (range 1-1247) and 31.5 days for vehicle (range 1-1302), median number of MC lesions at baseline was 12 for VP-102 (range 1-184) and 16 for vehicle (range 1-110). Significant differences between groups achieving ≥75% and ≥90% clearance were seen as early as D21 (p<0.0001 respectively) and continued at each time point to EOS. At EOS 77.7% of VP-102 subjects achieved ≥75% reduction in lesions vs. 34.9% for vehicle. 8% of VP-102 subjects achieved ≥ 90% clearance of all lesions at EOS vs. 27.1% for vehicle (p<0.0001 respectively). Most common treatment-related AEs reported included application site blistering, pruritus, pain and erythema, were mild to moderate in severity, and were anticipated based on the mechanism of action of VP-102. Discontinuation due to AEs occurred in 6 (1.9%) subjects in the VP-102 group and 1 (0.5%) in the vehicle group.
- Conclusions: Subjects in the VP-102 group showed significantly higher rates of ≥75% and ≥90% lesion clearance than subjects in the vehicle group as early as D21. The significant reduction of MC lesions may lead to reduced viral burden, risks of auto-inoculation, and potential transmission to others. Treatment with VP-102 was well-tolerated as evidenced by low discontinuation rates due to AEs. Trials were sponsored by Verrica Pharmaceuticals, Inc.
- Safety and Efficacy of VP-102 in Molluscum Contagiosum (MC) by Lesion Count Quartile: Pooled results of two Phase 3 multicenter, randomized, vehicle-controlled trials for the topical treatment of MC. Eichenfield LF, Kwong P, Gonzalez M, et al. American Academy of Dermatology, June 2020.
- Background: Two Phase 3 trials were completed using VP-102, a proprietary drug- device combination containing cantharidin (0.7% w/v) for the treatment of molluscum contagiosum (MC). This pre-specified exploratory analysis aimed to determine if lesion count at baseline affected the safety and efficacy outcomes in response to VP-102 by pooling data from both trials.
- Methods: Subjects ≥ 2 years of age with MC were enrolled in two trials with identical protocols and randomized 3:2 to topical administration of VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or a maximum of 4 applications. Lesion counts were recorded by assessors blinded to treatment at days 21, 42, 64, and at end of the study visit (day 84). Adverse events (AE) were documented throughout the study with a specific focus on local site reactions. Subjects were separated into quartiles by baseline lesion count.
- Results: For the ITT population, VP-102 n=309. Quartiles (Q) were as follows: Q1:1-7 lesions (n=92); Q2: 8-14 lesions (n=82); Q3:15-28 lesions (n=67); Q4:≥29 lesions (n=68). In subjects treated with VP-102 complete clearance at D84 was similar and statistically significant compared to vehicle for all quartiles (range 43%-63%). Reduction in percent change in lesion count was similar in all quartiles, and highest in Q4 at D84 (-89.8%). Most common AEs including application site vesicles, pain, erythema, and pruritus were similar across groups.
- Conclusions: Treatment of MC with VP-102 showed similar safety and efficacy across all lesion count groups.
- Safety and Efficacy of VP-102 (0.7% w/v cantharidin) in Molluscum Contagiosum (MC) by Lesion Location: Pooled Results of Two Phase 3 Multicenter, Randomized, Vehicle-Controlled Trials. Eichenfield LF, Yan A, Kwong P, et al. Winter Clinical Dermatology Symposium, January 2020.
- Background: VP-102 is novel proprietary drug-delivery device combination containing a controlled formulation of cantharidin (0.7% w/v) and has undergone Phase 3 trials for the treatment of molluscum contagiosum (MC). This post-hoc analysis aimed to determine the pooled safety and efficacy of VP-102 by MC lesion location, segmented by body area including head/neck, chest/abdomen, upper extremities, back/buttocks, groin, and lower extremities.
- Methods: Subjects ≥ 2 years of age with MC were consented and enrolled in two Phase 3 trials with identical protocols and randomized in a 3:2 ratio of topical administration of VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or up to a maximum of 4 applications. Lesion counts and locations were recorded at days 1 (baseline), 21, 42, 63, and 84 (the end of study (EOS) visit). The efficacy population included subjects with lesions in the specific locations at baseline. Efficacy was measured by the percentage of subjects with complete clearance of lesions in each location by visit. Targeted adverse events (AEs) were documented throughout the study with a specific focus on local site reactions. The safety population included subjects who received a treatment in the designated area on that specific visit day. Subjects could have had lesions in more than one area, and individual lesions were not tracked.
- Results: Subjects had MC lesions in specific areas at baseline including head/neck (n=77 patients in the VP-102 group, n=53 for vehicle), upper extremities (n=179, 131), lower extremities (n=186, 141), back/buttocks (n=117, 91), groin (n=28, 25), or chest/abdomen (n=142, 118). The percentage of subjects with complete clearance of all molluscum lesions was statistically significantly higher in the VP-102 group than vehicle in all areas at the EOS visit and ranged from 61-86% for VP-102 and 33-52% for vehicle (p-values ranged from <0.001 to 0.0076 for each anatomic site). Incidence of targeted AEs were consistent across regions for the VP-102 group; detailed incidence of AEs will be shown.
- Conclusions: The most common areas for subjects to have MC lesions at baseline included lower extremities, upper extremities, and chest/abdomen. Treatment of MC with VP-102 showed statistically significantly higher efficacy of percentage of patients with complete clearance vs. vehicle across all body locations. The VP-102 group showed similar incidence of AEs across all body locations.
- Responder characteristics in molluscum contagiosum (MC) subjects treated with VP-102 achieving complete clearance: Pooled results of two Phase 3 multicenter, randomized, vehicle-controlled trials for the topical treatment of MC. Eichenfield LF, Cohen SR, Pelletier J, et al. American Academy of Dermatology, June 2020.
- Background: VP-102 is a proprietary drug-device combination containing cantharidin (0.7% w/v) that has been tested for the treatment of molluscum contagiosum (MC) in two Phase 3 clinical trials. Post-hoc analysis of pooled data from the VP-102 group in these trials examined the characteristics of subjects with or without complete clearance of MC in response to treatment with VP-102.
- Methods: Subjects ≥ 2 years of age (age range 2-60) with MC were enrolled in two trials with identical protocols and randomized 3:2 to topical administration of VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or a maximum of 4 applications. Assessors blinded to treatment counted MC lesions at days 21, 42, 63, and at end of the study (EOS) visit (day 84). VP-102 subjects with complete clearance of MC lesions by EOS were considered responders. Data were analyzed for adverse events (AEs), baseline (BL) demographics, and MC characteristics in responders vs. non-responders.
- Results: In the subjects treated with VP-102, responders (n=155) and non-responders (n=155) had similar demographic (age, sex, ethnicity, and race) characteristics including time since MC clinical diagnosis and similar incidence of AEs. Lesion counts of non-responders was somewhat higher (median 25.35 vs. 20.26 p<0.05)
- Conclusions: Responders and non-responders to VP-102 were similar in demographic BL characteristics and incidence of AEs. Safety was similar across groups regardless of response. This data suggests that any patient within the requirements of the study protocol could be a candidate for response to VP-102.
- Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in the Treatment of Molluscum Contagiosum by Body Region and Visit. Eichenfield LF, Yan A, Kwong P, et al. Winter Clinical Dermatology Symposium 2021
- Background: VP-102 is proprietary drug-device combination product containing a controlled topical formulation with cantharidin (0.7% w/v) and has completed Phase 3 trials for the treatment of molluscum contagiosum (molluscum). Post-hoc analyses determined the pooled safety and efficacy of VP-102 at each visit by molluscum lesion body region where lesions were present at baseline, segmented by head/neck, chest/abdomen, upper extremities, back/buttocks, groin, and lower extremities.
- Methods: Subjects ≥ 2 years of age with a clinical diagnosis of molluscum were enrolled in two Phase 3 trials with identical protocols and randomized in a 3:2 ratio to topical administration of VP-102 or vehicle applied to all baseline and new molluscum lesions once every 21 days until clear, or up to a maximum of 4 applications. Lesion counts and body regions were recorded at days 1 (baseline), 21, 42, 63, and 84 (the end of study (EOS) visit). The efficacy population included subjects with lesions in the specific body regions at baseline. Efficacy was measured by the percentage of subjects with complete clearance of lesions in each location by visit. Lesions could be present in more than one body region, and individual lesions were not tracked. Targeted adverse events (AEs) were documented throughout the study with a focus on local skin reactions. The safety population included subjects who received at least one treatment of study drug.
- Results: Subjects had lesions in the following regions at baseline: head/neck (n=77 VP-102, n=53 vehicle), upper extremities (n=179, 131), lower extremities (n=186, 141), back/buttocks (n=117, 91), groin (n=28, 25), or chest/abdomen (n=142, 118). The percentage of subjects with complete clearance of all lesions was statistically significantly higher in the VP-102 group than vehicle in all body regions at the EOS visit. Clearance of Head/neck, chest/abdomen, back/buttocks, and upper extremities were statistically significantly higher than vehicle beginning after the first visit through the EOS visit (all p<0.05). Clearance rates of the lower extremities were significantly higher for VP-102 vs vehicle beginning at day 42, and in the groin beginning at day 63 through the EOS visit (p<0.05). All clearance rates will be presented in the poster. Incidence of targeted AEs were consistent across regions for the VP-102 group.
- Conclusions: Treatment of molluscum with VP-102 showed statistically significantly higher efficacy of percentage of subjects with complete clearance vs. vehicle across all body locations, though different body regions may require a different number of treatments for complete clearance. The VP-102 group showed similar incidence of AEs across all body regions.
Safety and Efficacy of VP-102 in Molluscum Contagiosum by Age: Pooled Results of Two Phase 3 Multicenter, Randomized, Vehicle-Controlled Trials Elaine Siegfried, Scott Katz, Pieter d’Arnaud, Melissa Olivadoti American Academy of Dermatology VMX (Virtual) April 23-26, 2021
Background: Molluscum contagiosum (molluscum) is a common viral skin infection predominately affecting children. VP-102 is a proprietary drug-device combination containing cantharidin (0.7% w/v). This analysis examined the pooled safety and efficacy data from two phase 3 clinical trials of VP-102 for treating molluscum, by subject baseline age.
Methods: Subjects ≥ 2 years of age with molluscum were enrolled in two identical phase 3 trials and randomized in a 3:2 ratio to receive either topical VP-102 or vehicle. Study drug was applied to all baseline and new lesions once every 21 days until complete clearance of lesions, or up to a maximum of 4 applications. Efficacy and safety were assessed by age (2-5yrs, 6-11yrs, 12-18yrs, and 19+yr), including percentage of subjects with complete clearance of all baseline and new lesions by D84 and treatment emergent adverse events (TEAEs) with a specific focus on local skin reactions.
Results: The percentage of subjects with complete molluscum clearance at D84 ranged from 46.4%-72.7% for VP-102 and 14.2%-20% for vehicle and was statistically significantly higher in all age groups at D84 for VP-102-treated subjects vs vehicle. The most common TEAEs for VP-102 were application site vesicles, pruritus, and scab. Incidence of TEAEs was similar across age groups.
Conclusions: Treatment of molluscum with VP-102 showed higher efficacy across all ages at D84. Earlier clearance, along with a higher incidence of blistering was noted in children under age 12. The VP-102 group showed similar incidence of TEAEs across all ages.