Search

Molluscum contagiosum (MC) is a benign cutaneous viral infection commonly affecting children, sexually active adults, immunocompromised individuals, and patients on immunosuppressive therapy. Giant periorbital MC lesions with preseptal cellulitis are rare. We present 2 such pediatric cases. Case 1 was a 9-month-old boy with an enlarging left upper eyelid mass and preseptal cellulitis. MC was confirmed on histopathology, and surgical excision was curative. Case 2 was an 18-month-old girl with a right lower eyelid ulcerating mass and preseptal cellulitis. She was managed with antibiotics and surgical excision., (Crown Copyright © 2024. Published by Elsevier Inc. All rights reserved.)

This comprehensive review article gives an up-to-date assessment of the therapeutic landscape for warts and molluscum contagiosum (MC), focusing on advances made in the last 5 years. New treatment choices include VP-102 (Ycanth) for molluscum contagiosum, potentially intralesional Vitamin D3 for warts, and topical cidofovir for both. Immunotherapy is regarded as a potential option, especially in difficult situations. Traditional therapies like cryotherapy and keratolytic medicines remain the principal options. The study emphasizes the need for personalized treatment strategies and additional research to improve therapy efficacy and safety., Competing Interests: Disclosure The authors declare no disclosures.. Authors’ contributions: K.K. Verma and K.M. Burningham wrote and revised the article and performed a literature review. S.K. Tyring revised the article. All authors approved the final article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

We recently developed compound FC-7269 for targeting the Molluscum contagiosum virus processivity factor (mD4) and demonstrated its ability to inhibit viral processive DNA synthesis in vitro and cellular infection of an mD4-dependent virus (Antiviral Res 211, 2023,105520). However, despite a thorough medicinal chemistry campaign we were unable to generate a potent second analog as a requisite for drug development. We overcame this impasse, by conjugating a short hydrophobic trivaline peptide to FC-7269 to produce FC-TriVal-7269 which significantly increased antiviral potency and reduced cellular toxicity., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Objective: Controlling molluscum contagiosum (MC) infections is critical in atopic dermatitis (AD) management. This post hoc analysis assessed the efficacy and safety of berdazimer gel, 10.3% (topical, antiviral, nitric oxide-releasing medication) versus vehicle in MC patients with or without AD., Methods: Three Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group trials (B-SIMPLE[berdazimer sodium in molluscum patients with lesions]1, -2, -4) enrolled patients 6 months and older with 3-70 mollusca. Berdazimer or vehicle was applied once daily to all MC lesions for 12 weeks. Data from three Phase 3 studies were integrated for subgroup efficacy and safety assessments using several weighted meta-analysis approaches. Patients with concurrent AD or a history of AD/eczema were categorized as AD+ subgroup (AD- when absent). Primary efficacy endpoint: complete lesion clearance at Week 12. Safety endpoints included adverse events (AEs) through Week 24 and local skin reactions through Week 12., Results: Of 1598 enrolled patients, 209 (13.1%) were AD+. Baseline mean lesion counts were greater in AD+ (26.4) than AD- (19.3). Complete clearance rates were higher at Week 12 for berdazimer compared with vehicle in AD+ (n = 209; 35.0% vs. 27.4%; odds ratio [OR], 1.3; 95% CI, 0.7-2.5) and AD- (n = 1389; 29.1% vs. 18.9%; OR 1.8; 95% CI 1.4-2.4) subgroups. AEs in AD+ were application-site pain (21.6% with berdazimer vs. 11.9% with vehicle), dermatitis (12.8% vs. 2.4%), and erythema (9.6% vs. 7.1%)., Conclusions: Berdazimer gel showed favorable efficacy regardless of AD status. Berdazimer-induced erythema may be indistinguishable from AD symptoms or with inflammatory response upon resolution of molluscum., (© 2024 Novan, A Ligand Company. Pediatric Dermatology published by Wiley Periodicals LLC.)

Berdazimer topical gel, 10.3% (ZELSUVMI™) is a nitric oxide (NO) releasing topical gel developed by Novan Inc. (a Ligand Pharmaceuticals company) for the treatment of molluscum contagiosum (MC). Novan has used their proprietary NO-based technology platform (NITRICIL™), which stores gaseous NO species on large polymers, in the development of berdazimer topical gel, 10.3%. In January 2024, berdazimer topical gel, 10.3% was approved for the topical treatment of MC in adult and paediatric patients 1 year of age and older in the USA. This article summarizes the milestones in the development of berdazimer topical gel, 10.3% leading to this first approval for the treatment of MC., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: An out-of-office therapeutic agent indicated for molluscum contagiosum is needed., Objective: To assess the efficacy and safety of berdazimer gel, 10.3% (a topical, antiviral, nitric oxide-releasing medication) versus vehicle., Methods: Berdazimer gel, 10.3% or vehicle was applied once daily to all molluscum contagiosum lesions for 12 weeks in patients ≥6 months with 3-70 mollusca. Efficacy assessment: complete lesion clearance and partial clearance at week 12. Safety and tolerability assessment: adverse events through week 24 and local skin reactions through week 12., Results: There were 1598 patients enrolled (n = 917 berdazimer, n = 681 vehicle). Berdazimer was superior to vehicle at week 12 in complete clearance rates, 30.0% versus 19.8% (odds ratio, 1.75; 95% CI, 1.38-2.23, P < .001). Subgroup analyses of primary efficacy showed consistent favorable efficacy for berdazimer across most subgroups, including age, sex, baseline lesion count, and disease duration. Berdazimer provided favorable outcome for partial clearance. Application-site pain (18.7% vs 4.8% in berdazimer vs vehicle) and erythema (11.7% vs 1.3%), mostly mild to moderate, were the most common local skin reactions., Limitations: Berdazimer sodium in molluscum patients with lesions (B-SIMPLE) trials enrolled only US patients; no efficacy assessments beyond week 12., Conclusions: Berdazimer gel, 10.3% showed favorable efficacy and safety across subgroups., Competing Interests: Conflicts of interest Dr Browning is an investigator for AbbVie, Amgen, Amryt, Arcutis, Concert, Dermavant, Eli Lilly, Leo, Novan, Novartis, Pfizer, Regeneron, UCB, and Vyne, a consultant for Castle Creek, Krystal, and Novartis, and a speaker for Pfizer and Regeneron. Drs Cartwright and Maeda-Chubachi and Author Enloe are employees of and stockholders in Novan, Inc. Dr Green is an investigator and consultant for Novan and a consultant, investigator, or speaker for Amgen, Alumis, Arcutis, Alumis, BMS, Candesant, Cara, Dermavant, Endo, EPI Health, Galderma, Highlittl, Incyte, Janssen, Lilly, OrthoDerm, and Verrica. Dr Hebert has received research grants paid to the McGovern School of Medicine from AbbVie, Arcutis, Novan, and Pfizer, has received honoraria from Pfizer, Arcutis, Incyte, Novan, Ortho Dermatologics, Amyrt, Galderma, Almirall, and is a member of Data Safety Monitoring Boards for GSK, Ortho Dermatologics, and Sanofi Regeneron. Dr Paller is an investigator for AbbVie, Dermavant, Eli Lilly, Incyte, Janssen, Krystal, Novan, and UCB, has received honoraria from Aegerion Pharma, Azitra, BioCryst, Boehringer Ingelheim, Bristol Myers Squibb, Castle Creek, Eli Lilly, Janssen, Krystal, LEO Pharma, Novartis, Regeneron, Sanofi/Genzyme, Seanergy, TWI Biotechnology, and UCB, and serves on the data safety monitoring boards for AbbVie, Abeona, Catawba, Galderma, and InMed. Dr Stripling is an adviser for Novan and an investigator for Arcutis Biotherapeutics and Novan. Dr Sugarman is a consultant and speaker for Cerave, Incyte, Regeneron, Sanofi, and Pfizer, a consultant for Galderma, Novan, Solgel, and Verrica, and an investigator for Bausch, Dermavant, Galderma, Hill, and Leo. Author Wells is an employee of Synteract, which received funding from Novan, Inc for the statistical analysis., (Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Molluscum contagiosum (MC) is a skin and mucous membrane infection caused by the molluscum virus (MCV). To evaluate safety and efficacy of intralesional injection of tuberculin purified protein derivative (PPD) antigen injection versus MMR (mumps, measles, rubella) antigen for the treatment of molluscum contagiosum (MC). A total of thirty clinically confirmed patients of molluscum were recruited for this trial. Patients who were divided into three groups (A, B and C). Each group consisted of (30) patients. Group (A) subjects received intralesional MMR injections, group (B) subjects received intralesional PPD injection and group (C) received intralesional saline injection. The results of the present study revealed complete clearance of the injected lesions in 12 patients (80%), partial response in 3 patients (20%) of group (A). In group (B), complete clearance of the treated warts was observed in 11 patients (73.3%) and partial response in 4 (26.7%) of patients. In group (C), the majority of patients 8 (53.3%) demonstrated no response while 7 (46.7%) patients showed only partial clearance. We established a good safety and efficacy profile for tuberculin PPD and MMR antigens in treatment of molluscum contagiosum., (© 2024. The Author(s).)

Cantharidin (YCANTH™) is a proprietary drug-device combination product containing a formulation of cantharidin 0.7% topical solution (a vesicant naturally derived from blister beetles) delivered via a single-use applicator that has been developed by Verrica Pharmaceuticals Inc. for the treatment of molluscum contagiosum and is also being developed for the treatment of warts. In July 2023, YCANTH™ (cantharidin 0.7% topical solution) was approved for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older in the USA. This article summarizes the milestones in the development of cantharidin 0.7% topical solution leading to this first approval for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older., (© 2023. Springer Nature Switzerland AG.)

Background: Molluscum contagiosum (MC) can cause significant burden in children. So far, pharmacological treatment has not been proven beneficial. More rigorous interventions have not been well studied. Current guidelines advise a "wait and see" policy. However, children and their parents frequently visit their GP requesting intervention. Therefore, the aim of this study was to gain insight into the approach to MC by GPs and parents' expectations and to investigate willingness to participate in an interventional study., Methods: A survey study was carried out among GPs and parents using a questionnaire for each group inquiring about MC and potential study participation. Descriptive statistics were used to analyze results and logistical regression to investigate factors influencing participation., Results: The majority of GPs (88%) preferred an expectative approach; only 21% were willing to participate in a trial as proposed. GPs estimating ≥ 50% of parents would request treatment, were more likely to participate. Most responding parents did or would visit their GP requesting treatment. In contrast to GPs, 58% were willing to participate. Parents preferring cryotherapy or curettage were more likely to participate., Conclusion: Our study demonstrated that the majority of GPs preferred a conservative approach, adhering to current guidelines. However, most parents preferred treatment to resolve MC and symptoms. Parents' willingness to participate was much higher than GP's, reflecting parents' desire for treatment. These findings underscore the need for continued therapeutic research. Careful preparation and selection of GPs and patients will be essential to ensure the feasibility of such an endeavor., Trial Registration: This survey study was not part of a clinical trial., (© 2023. The Author(s).)

Molluscum contagiosum (MC) is characterized by skin lesions containing the highly contagious molluscum contagiosum poxvirus (MCV). MCV primarily infects children, with one US Food and Drug Administration (FDA)-approved drug-device treatment in use but no approved medications. Assessing antivirals is hindered by the inability of MCV to replicate in vitro. Here, we use vaccinia virus as a surrogate to provide evidence of the anti-poxvirus properties of berdazimer sodium, a new chemical entity, and the active substance in berdazimer gel, 10.3%, a nitric oxide-releasing topical in phase 3 development for the treatment of MC. We show that berdazimer sodium reduced poxvirus replication and, through a novel methodology, demonstrate that cells infected with drug-treated MCV virions have reduced early gene expression. Specifically, this is accomplished by studying the nuclear factor kappa-light-chain-enhancer of activated B cell (NF-kB)-blocking protein MC160 as an example of an early gene. The results provide a plausible unique antiviral mechanism of action supporting increased MCV resolution observed in patients treated with berdazimer gel, 10.3% and describe a novel methodology that overcomes limitations in investigating MCV response in vitro to a potential new MC topical medication.

YCANTH TM (cantharidin) topical solution has been approved recently for the treatment of molluscum contagiosum (MC) in children (aged ≥2 years) and adults. It works by activating serine proteases that lead to blistering and inflammation, promoting shedding of infected cells and viral clearance. In two phase-3, randomized, double-blind, vehicle-controlled trials of similar design, VP-102 (a drug-device combination, containing cantharidin 0.7% w/v and inactive ingredients, such as gentian violet, acetone, and denatonium benzoate, administered with an applicator) was investigated for the treatment of MC. VP-102 and vehicle were applied topically once every 21 days until complete clearance of lesions was observed, or for up to four treatments. Cantharidin demonstrated efficacy in achieving the primary outcome, at day 84/visit 4 (Cantharidin Application in Molluscum Patients [CAMP-1], VP-102: 46% [73/160], vehicle: 18% [19/106]; and CAMP-2, VP-102: 54% [81/150], vehicle: 13% [15/112]). Common adverse events were mild to moderate, such as lesions at the site of application, pruritus, and pain. The recommended regimen of cantharidin topical solution is its application once every 21 days until complete clearance of lesions is observed, or up to four treatments.

Molluscum contagiosum (MC) is a contagious infection that, although benign, can become an aesthetic burden and lead to other opportunistic infections, secondary dermatitis, and self-isolation. Currently, several treatment options are available for MC, including the newly investigated nitric oxide-releasing berdazimer gel, leading this review to evaluate randomized controlled trials (RCT) comparing berdazimer gel with a vehicle for treating MC. The meta-analysis included three reports and four RCT involving 1854 patients, with 1106 (59.6%) randomized to receive berdazimer. Our findings suggest that berdazimer is effective in the management of MC lesions, but the increased clearance of lesions and reduction of scarring must be weighed against the potential for topical adverse effects, particularly when considering the use of this therapy in pediatric patients., (© 2023 Wiley Periodicals LLC.)

Background and Objectives: Various interventions have been applied to treat molluscum contagiosum, but benefits and efficacy remain unclear. To assess the comparative efficacy and safety of interventions for molluscum contagiosum, a network meta-analysis was performed., Patients and Methods: Embase, PubMed, and the Cochrane Library were searched for articles published between January 1, 1990, and November 31, 2020. Eligible studies were randomized clinical trials (RCTs) of interventions in immunocompetent children and adults with genital/non-genital molluscum contagiosum lesions., Results: Twelve interventions from 25 RCTs including 2,123 participants were assessed. Compared with the placebo, ingenol mebutate had the most significant effect on complete clearance (odds ratio [OR] 117.42, 95% confidence interval [CI] 6.37-2164.88), followed by cryotherapy (OR 16.81, 95% CI 4.13-68.54), podophyllotoxin (OR 10.24, 95% CI 3.36-31.21), and potassium hydroxide (KOH) (OR 10.02, 95% CI 4.64-21.64). Data on adverse effects were too scarce for quantitative synthesis., Conclusions: Ingenol mebutate, cryotherapy, podophyllotoxin, and KOH were more effective than the other interventions in achieving complete clearance, but safety concerns regarding ingenol mebutate have recently been reported. Due to the possibility of spontaneous resolution, observation is also justified for asymptomatic infection. Factors including adverse effects, cost, patient preference, and medical accessibility should be considered., (© 2023 Deutsche Dermatologische Gesellschaft (DDG).)

Competing Interests: Competing interests: None declared.

Molluscum contagiosum virus (MCV) is an infection caused by the molluscum contagiosum virus . Antiviral medications used to treat MCV infections have several problems, including drug-resistant and toxicity. As a result, improving safe, innovative, and effective antiviral drugs is critical. Therefore the current study aimed to investigate ZnO-NPs effects on M. contagisum infection and molluscum contagiosum virus replication, among the main exciting viruses that menace human health. The antiviral activity of zinc oxide nanoparticles (ZnO-NPs) against MCV infection was investigated in this work. FESEM and TEM electron microscopy were used to examine the nanoparticles. The cytotoxicity of the nanoparticles was assessed using the MTT assay, and anti-influenza effects were detected using RT-PCR and TCID50. An indirect immunofluorescence experiment was used to investigate the inhibitory effect of nanoparticles on viral antigen expression. In all tests, acyclovir was employed as a control. Compared to virus control, post-exposure of MCV with ZnO nanoparticles at the highest dose but is not toxic (100 g/mL) resulted in 0.2, 0.9, 1.9, and 2.8 log10 TCID50 reductions in infectious diseases virus titer (P=0.0001). This ZnO-nanoparticles level was accompanied by an inhibition percentage (17.8%, 27.3%, 53.3%, 62.5 %, and 75.9%), respectively, measured based on viral load compared with the virus control. Compared to the positive control, fluorescence emission intensity in virally infected cells that administrated ZnO nanoparticles was statically decreased. Our findings demonstrated that ZnO-NPs have antiviral effects against the MCV. This property indicates that ZnO-NP has a high potential for usage in topical formulations to treat facial and labial lesions., Competing Interests: The authors declare that they have no conflict of interest.

Background: Molluscum contagiosum (MC) is an acute infection caused by the molluscum contagiosum virus (MCV) with a worldwide incidence of approximately 8,000 cases per 100,000 individuals annually. Greater than 90% of MC cases occur in the pediatric population, and affected adults are more likely to be younger or immunocompromised. MC has minimal inflammation initially; however, a strong inflammatory response can occur during resolution of the infection, termed the beginning of the end (BOTE). MC infections may last months to years, and it is hypothesized that persistent infections may be due to suppression of immunity by MCV proteins, thus affecting MC&rsquo;s clinical progression., Objective: We reviewed the current proposed mechanisms of MCV immune evasion and discuss potential therapeutic options for MC treatment., Methods: A literature search was conducted using electronic databases (Pubmed, Google Scholar, Medline)., Results: We compiled 18 original research articles and identified 11 proteins produced by MCV that are postulated to participate in evasion of host immunity through various molecular pathways. These proteins and/or their downstream pathways may be influenced by MC treatments in phase 3 development, including berdazimer gel 10.3% and VP-102 cantharidin, 0.7%., Conclusion: MCV is distinctive in evading immune surveillance by inhibiting or dampening several immune pathways via the production of viral proteins. The result is decreasing local inflammatory response which contributes to the prolonged survival of MCV in the epidermis. Persistent MC can be a nuisance for some patients and treatment may be desired. Currently, no treatment has been approved by the US Food and Drug Administration (FDA). Two approaches in the pipeline may affect the immune avoidance mechanisms; nevertheless, their exact mechanisms between the potential therapeutics and viral proteins remain enigmatic. J Drugs Dermatol. 2023;22(2):182-189. doi:10.36849/JDD.7230.

Background: Molluscum contagiosum is often characterized by persistent lesions and bothersome symptomology. What patients with molluscum contagiosum and/or caregivers consider to be meaningful measures of therapeutic success is unknown., Objective: We aimed to collect patient experience data and assess Global Impression of Change from patients and/or caregivers participating in a large phase III molluscum contagiosum interventional trial., Methods: The Berdazimer Sodium In Molluscum Patients with LEsions (B-SIMPLE4) phase III study enrolled 891 patients with molluscum contagiosum. Patients were randomly assigned to berdazimer gel, 10.3% or vehicle gel applied once daily for 12 weeks. Assessments of participant and investigator perceptions of complete lesion clearance were collected at weeks 12 and 24 along with Global Impression of Change scores from 1 (very much improved) to 7 (very much worse). A subset of 30 B-SIMPLE4 patients participated in the patient/caregiver experience exit interview to evaluate bothersome signs and symptoms., Results: At week 12, among participants with a ≥ 75% molluscum contagiosum lesion count reduction from baseline (as assessed by investigators), 99% (373/376) reported improvement. Perceptions of complete clearance at week 12 were nearly 40% for both participant-reported and investigator-reported Global Impression of Change in berdazimer group vs 20% in the vehicle group: 82% (322/392) of participants in the berdazimer group and 60% (237/394) in the vehicle group reported their molluscum contagiosum lesions were either very much improved or much improved at week 12. Similarly, investigators scored 80% (314/393) of berdazimer and 54% (215/396) of vehicle participants as very much improved or much improved. From the exit interview, the mean duration of participant-reported molluscum contagiosum was nearly 2 years. The most frequently reported molluscum contagiosum-related signs and symptoms were itch (n = 20), scarring (n = 18), and pain (n = 13). Visibility and contagiousness of molluscum contagiosum were the most bothersome aspects to participants. The most frequently reported psychosocial impacts were self-consciousness (n = 15) and embarrassment (n = 14). Lesion clearance was an expectation of 28/30 study participants. Overall, 26/30 reported being very satisfied (n = 18) or satisfied (n = 8) with the changes in their disease over the duration of the trial; 23/30 stated that the change in lesion count was meaningful. A mean reduction of 18 lesions (76% decrease) from the baseline lesion count was reported by participants (n = 28). Although 22 of 28 had less than complete lesion clearance, 17 of 22 reported that the reduction in the number of lesions was meaningful., Conclusions: Molluscum contagiosum lesion reductions, with or without complete clearance, may be considered a therapeutic "success" by the patient/caregiver., Clinical Trial Registration: NCT04535531 (registered 2 September, 2020)., (© 2022. The Author(s).)

Objective: To address the gap in evidence related to molluscum contagiosum in children by focusing on demographic and clinical features as well as risk factors., Methods: The multicentre, prospective, clinical study was conducted at four hospitals in Ankara and Tokat cities of Turkey from August 1, 2014, to August 5, 2019, and comprised patients aged ≤18 years diagnosed with molluscum contagiosum. Data about demographics, day nursery and preschool attendance, the seasons when the disease occurred, any use of Turkish baths and swimming pools, history of personal/familial atopy, coexistence of diseases, disease duration, courses, number of lesions and anatomic localisation. Data was analysed using SPSS 19., Results: Of the 286 patients, 130(45.5%) were girls and 156(54.5%) were boys. The overall mean age was 5.94±3.95 years. The median duration of the disease was 5 weeks (interquartile range: 3.00-12.00 weeks). There was a significant number of cases with family history 18(48.6%) in the 0-3 age group (p=0.027). History of personal atopy was significantly high in the winter season (p<0.05). Patients with >20 lesions had used swimming pools significantly more frequently than the rest (p=0.042). The trunk was the most commonly involved region 162(56.6%)., Conclusions: Providing prospective data about demographics, clinical characteristics and risk factors of molluscum contagiosum in children will lead to appropriate preventive and therapeutic measures.

That cidofovir, an acyclic nucleoside phosphonate (ANP), was inhibitory to the replication of poxviruses was first demonstrated by De Clercq et al.. That its active metabolite, the diphosphate, was found to be inhibitory to the molluscum contagiosum ( M. contagiosum ) DNA polymerase was demonstrated by Watanabe and Tamaki. Twelve different independent observations have then indicated that cidofovir administered intravenously, topically or intralesionally is efficacious in the treatment of M. contagiosum mostly in immunosuppressed patients.

Competing Interests: Conflicts of interest None disclosed.

Background: Berdazimer (SB206), gel 10.3% is a novel, topical, nitric oxide&ndash;releasing agent intended for molluscum contagiosum (MC) treatment., Methods: A 12-week, open-label, multicenter trial evaluated the safety, tolerability, and pharmacokinetic (PK) parameters of berdazimer gel, 10.3% applied topically once daily for the treatment of MC. Patients were aged &ge;6 months with &gt;20 molluscum lesions. The primary endpoint was the PK profile of the hydrolyzed N-methylaminopropyl-trimethoxysilane (hMAP3) monomer and nitrate during a 2-week period of once-daily berdazimer gel, 10.3% application (PK period) under maximal use conditions. Safety and tolerability were evaluated throughout the 12-week study period., Results: Half of the 34 enrolled patients (17) were female and most (97.1% [33/34]) were white. Patients were 2 to 12 years old (mean, 5.3 years) with a mean of 50 MC lesions at baseline (mean time since MC awareness, 12.4 months). No patients had quantifiable plasma hMAP3 concentrations on day 1. On day 15, 2 patients had quantifiable plasma hMAP3 concentrations; however, the maximum concentration (33.9 ng/mL) was &gt;10-fold lower than the no observed adverse effect level (NOAEL) in an animal toxicology study. Mean nitrate concentration&ndash;time profiles were similar on days 1 and 15 and remained flat for all patients throughout the 2-week PK period. The highest plasma methemoglobin level observed was 3.2%. Application-site pain (13/34 [38.2%]) and application-site erythema (6/34 [17.6%]) were the most frequent treatment-emergent adverse events (TEAEs), and most TEAEs were mild or moderate., Conclusions: Once-daily berdazimer gel, 10.3% was well-tolerated with minimal systemic absorption. J Drugs Dermatol. 2022;21(10):1104-1110. doi:10.36849/JDD.6938.

Importance: Molluscum contagiosum (MC) is a highly contagious skin condition. Lesions may persist for months to years, and no US Food and Drug Administration-approved medications are currently available in the US., Objective: To assess the efficacy and safety of berdazimer gel, 10.3%, a novel topical nitric oxide-releasing medication, in the treatment of MC., Design, Setting, and Participants: This was a multicenter, vehicle-controlled, double-blind, phase 3 randomized clinical trial (B-SIMPLE4) conducted in 55 clinics (mostly dermatology and pediatric) in the US from September 1, 2020, to July 21, 2021. Eligible participants were 6 months or older and had from 3 to 70 raised MC lesions. Patients with sexually transmitted MC or with MC only in the periocular area were excluded., Interventions: Patients were randomized to treatment with berdazimer gel, 10.3%, or vehicle gel, applied as a thin layer to all lesions once daily for 12 weeks., Main Outcomes and Measures: The primary efficacy end point was complete clearance of all MC lesions at week 12. Safety and tolerability measures included adverse event frequency and severity, and assessment of local skin reactions and scarring. Data analyses were performed from August 31, 2021, to September 14, 2021., Results: A total of 891 participants were randomized, 444 to berdazimer, 10.3% (mean [range] age, 6.6 [0.9-47.5] years; 228 [51.4%] male; 387 [87.2%] White individuals), and 447 to vehicle (mean [range] age, 6.5 [1.3-49.0] years; 234 [52.3%] female; 382 [85.5%] White individuals). In the intention-to-treat population, 88.5% (393 patients) in the berdazimer group and 88.8% (397 patients) in the vehicle group had a lesion count performed at week 12. At week 12, 32.4% (144 patients) in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% (88 patients) in the vehicle group (absolute difference, 12.7%; odds ratio, 2.0; 95% CI, 1.5-2.8; P < .001) with 14.4% (64 patients) of the berdazimer group discontinuing treatment because of MC clearance compared with 8.9% (40 patients) of the vehicle group. Adverse event rates were low. The most common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% (18 patients) of the berdazimer group and 0.7% (3 patients) of the vehicle group. The most common local skin reaction was mild to moderate erythema., Conclusions and Relevance: Use of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates., Trial Registration: ClinicalTrials.gov Identifier: NCT04535531.

Background: Molluscum contagiosum (MC) is a self-limited cutaneous viral infection. Topical 10% potassium hydroxide (KOH) has been used for treating MC. However, it remains unclear whether it is beneficial or not to apply topical 10% KOH for treating MC., Methods: To confirm the efficacy and safety of topical 10% KOH compared with placebo as well as other treatments for MC, meta-analysis was used. Up to September 2020, we performed a comprehensive search of literature based on three databases with following keywords including 'molluscum contagiosum' and 'potassium hydroxide'., Results: Our meta-analyses demonstrated a significant difference between topical 10% KOH and placebo for complete clearance of MC (RR: 2.96, 95% CI: 1.69 - 5.17, p  = .0001), while there were no statistical differences between them in the number of patients with adverse events (RR: 1.73, 95% CI: 0.67 - 4.45, p  = .2562). Also, topical 10% KOH was as effective as mechanical treatments for MC (RR: 0.95, 95% CI: 0.84 - 1.07, p  = .3833)., Conclusion: We demonstrate that application of topical 10% KOH may be one of effective and appropriate methods for the treatment of MC compared with awaiting spontaneous resolution due to its safety and effectiveness.

Background: Although molluscum contagiosum virus (MCV) infection is a common disease widespread among children and young adults, there is no shared opinion on treatment that can be divided into physical, chemical, medical (immunomodulating or anti-viral). According to some authors, MCV is best left to clear by itself., Objectives: To assess the clearance of MCV lesions in a sample of pediatric patients. It compares outcomes in treated with Imiquimod cream, compared with non-treated patients., Methods: The sample consits of 48 pediatric patients affected by MVC clinically diagnosed. It was divided into two groups: Group I, treated with Imiquimod 5% cream once/day until the onset of a visible inflammatory reaction. Once the reaction was illicited, application was suspended until the irritation resolved. If the lesion was still present, drug was administered again using the same regimen. The cycle was repeated until complete clinical resolution. Group II, control, comprises non-treated patients. Follow up visits were carried out 12, 16, 20, 48, and 52 weeks from the beginning of treatment., Results: At week 20, all patients except one in the treated group were lesion free. Persistence of MCV lesions was documented in one patient only until week 48. In the control group all patients were still affected by MCV lesions during the follow-up period. Spontaneous clinical resolution of the infection was observed in only 2 patients at week 52. The results of the study show Imiquimod's significant efficacy., Conclusions: Our study is one of the few case-control studies in pediatric population carried out with such long-term follow-up. Efficacy of this personalized treatment, scarce recurrence, absence of cicatricial sequelae and lack of necessity for deep sedation, in the case of children with disseminated lesions, makes the use of Imiquimod the first line of treatment compared with other destructive treatments or with no-treatment at all.

Background and Objectives: Molluscum contagiosum (MC) is a common viral infection. Hypersensitivity reactions reminiscent of Gianotti-Crosti syndrome, termed Gianotti-Crosti syndrome-like reaction (GCLR), have been reported in a subset of patients. We report a series of patients with GCLR, better delineating its clinical presentation and course., Patients and Methods: Retrospective chart review of all children presenting with GCLR at our Pediatric Skin Center between 2015 and 2020., Results: 26 children (14 boys) with a median age of 6.5 (3-11.3) years were included. GCLR involved the extensor surfaces of the extremities in all patients. More widespread eruptions also affected the trunk and face in 7 (27 %) and 6 (23 %) children respectively. Involvement of the skin overlying the Achilles tendons was a new finding in 4 (15 %) children. Itch was the predominant symptom in 20 (77 %) patients. The rash responded to topical and/or systemic corticosteroids and resolved within four weeks. GCLR was followed by clearance of MC in all patients within 9 (4-24) weeks., Conclusions: GCLR is a characteristic acute, wide-spread, pruritic papular eruption, which often leads to emergency consultations and anxiety in affected patients. GCLR responds well to corticosteroid treatment, has a benign course, and heralds the healing of MC., (© 2021 The Authors. Journal der Deutschen Dermatologischen Gesellschaft published by John Wiley & Sons Ltd on behalf of Deutsche Dermatologische Gesellschaft.)

Molluscum contagiosum (molluscum) is a common skin condition, especially in children, yet treatment approaches by US health care practitioners vary widely. A dearth of clinical data from large, well-controlled studies has resulted in significant gaps in knowledge, including treatment guidelines and algorithms. As of this writing, there are no FDA-approved treatments for molluscum. The objective of this review is to provide practitioners with expert, evidence-based information and guidance about treatment approaches for, and the special circumstances faced by, patients with molluscum. To this end, a group of five pediatric and adult dermatologists collectively identified treatments and special considerations they felt were most commonly used to treat molluscum. Hence, in the first part of the review, seven treatment approaches identified as the most important to review (e.g., curettage, cantharidin) are discussed in terms of their mechanisms of action, supporting clinical data, and rationale for use. Each treatment approach concludes with a &ldquo;clinical pearls&rdquo; section, which summarizes the group&rsquo;s experiences with the treatment. In the second part, five special considerations (e.g., atopic dermatitis, skin of color) are discussed with supporting clinical data and are also followed by a &ldquo;clinical pearls&rdquo; summary. J Drugs Dermatol. 2021;20(11): 1185-1190. doi:10.36849/JDD.6383.

Objectives: Molluscum contagiosum (MC) is viral skin infection that is most commonly observed in children. Zinc homeostasis is essential for proper immune function, especially in host-virus interactions. This study aimed to investigate the effectiveness of oral zinc sulfate treatment in children with MC., Methods: The subjects included 23 children with MC and 30 age/sex-matched healthy children as controls. Children with MC received oral zinc sulfate for 2 mo, and serum zinc levels were measured before and after the treatment period. Patients were examined every 4 wk for evidence of partial or complete lesion regression. Lesion numbers were recorded before treatment and during follow up., Results: The mean serum zinc levels in children with MC did not differ from those in controls (80.57 ± 10.14 vs 81.90 ± 8.47 μg/dL, respectively, P = 0.370). After zinc sulfate supplementation, the mean serum zinc levels increased from 80.57 ± 10.14 to 100.5 ± 9.95 μg/dL (P < 0.001) in subjects with MC. After a 2-mo treatment period, six subjects exhibited resolution of lesions at the 1-mo follow up, 10 subjects at the 2-mo follow-up, and three subjects at the 3-mo follow up. Disease recurrence was not observed. A 6-y-old boy and two 4-y-old girls without other systemic symptoms had MC lesions that persisted after zinc sulfate therapy and throughout the 1-y follow up. One female subject experienced complete recovery in after treatment month 4, but recurrence was observed in month 7 and persisted for 18 mo., Conclusions: Our findings support the use of oral zinc sulfate as a therapy for children with MC., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Although molluscum contagiosum (MC) is a common infectious dermatosis that is self-resolving, treatment can diminish discomfort and decrease the risk of autoinoculation and infection to others, because it is transmitted through direct skin contact. This systematic review evaluates the efficacy of topical treatments for MC. A PubMed search following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was performed to find randomized, controlled trials of MC treatment. The search yielded 129 publications, but only 15 studies published between 1994 and 2020 were found to fit the inclusion criteria. Treatment modalities included podophyllotoxin, imiquimod, sodium nitrite, myrtle leaf extract, phenol, Salatac Gel (salicylic acid with lactic acid), potassium hydroxide, cantharidin, SB206, and VP-102. Outcomes were extracted from the literature, and subsequent quality and risk of bias assessments were performed. All treatments were more efficacious than the control except cantharidin, potassium hydroxide, and imiquimod, which had varying degrees of efficacy throughout studies. Overall, studies were of sufficient quality and had low risk of bias, but they had small sample sizes and lacked adequate explanation of statistical analysis. Current first-line treatment entails mechanical methods such as cryotherapy and curettage, which may be frightening to children with MC, so the development and assessment of topical treatments allows for alternative efficacious techniques., Competing Interests: Conflict of interest The authors declare no conflict of interest., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Many over-the-counter (OTC) products are marketed to treat molluscum contagiosum, a common childhood viral infection with an estimated point prevalence of 5%-11%. As optimal treatment has not been defined, a comprehensive internet search was performed to identify OTC products marketed for treating molluscum and to collect information on packaging, ingredients, application instructions, and dosing. Nine OTC products were identified and varied widely in cost, packaging size, and ingredients; six of the nine products contained Thuja occidentalis. Overall, the majority of OTC package labels do not include sufficient information about their plant-based ingredients or appropriate dosing., (© 2021 Wiley Periodicals LLC.)

Molluscum contagiosum (MC) is a viral skin infection seen in children, sexually active adults and immunocompromised populations. It is usually a self-limiting illness that typically spontaneously resolves without therapeutic intervention. However, when the papules are extensive or refractory causing complications or aesthetic issues, multiple treatment modalities exist to relieve symptoms, limit spread and decrease the social stigma associated with visible lesions. Treatment is especially important in HIV/AIDS infected populations, where prevalence is estimated between 5% and 18% and susceptibility to larger, widespread and recalcitrant lesions involving atypical distributions is more common. We evaluated a 38-year-old woman with a history of AIDS (CD4+ T cell count <25 cells/µL) and poor adherence with antiretroviral therapy who presented with a 9-month history of persistent, progressively worsening facial and truncal umbilicated papules consistent with recalcitrant MC refractory to cidofovir injections. She was successfully treated with paclitaxel with complete resolution of the lesions after four cycles without adverse effects., Competing Interests: Competing interests: None declared., (© BMJ Publishing Group Limited 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Trial Registration: ClinicalTrials.gov identifiers: NCT03377790 (first posted 19 December 2017) and NCT03377803 (first posted 19 December 2017). Video abstract: 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 (MP4 131293 KB).

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&ndash;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&ndash;15) years, with a mean lesion count of 30 (26.1, 3&ndash;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. ClinicalTrials.gov identifier: NCT03186378 J Drugs Dermatol. 2021;20(1):70-75. doi:10.36849/JDD.5626.

Molluscum contagiosum (MC) is a mucocutaneous viral infection, often self-limiting but untreated lesions can often last for 2 months to 2 years. Previously intralesional measles, mumps, and rubella (MMR) vaccine has been tried for the treatment of warts but no studies exist of its use in MC. We report our experience with intralesional MMR in 22 patients of MC. The study was carried out to assess the efficacy and safety of intralesional MMR vaccine in patients of MC. We retrospectively analyzed records of patients who received intralesional MMR for MC from September 2018 to September 2019. Demographic characteristics, number, size, and site of molluscum lesions, number of MMR injections given, and response were recorded. Records of 22 patients were analyzed. There were 10 males and 12 females. The age of the patients ranged from 6 to 50 years with a mean of 19.72 ± 10.92. At the end of 12 weeks, 18 patients (81.8%) had complete clearance of lesions, with 4 patients (18.18%) having a partial response of more than 50%. No patient showed less than 50% or no response. In only one patient who had giant molluscum, postinflammatory hyperpigmentation was noted. No other adverse effect was seen in any of the patients. MMR is a safe, effective, easy to administer, time-saving, and inexpensive therapy for lesions of MC., (© 2020 Wiley Periodicals LLC.)

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.

Background: The immune system plays an important part in the clearance of molluscum contagiosum (MC) and, therefore, there has lately been a trend in using immunotherapy in MC therapy. Tuberculin-purified protein derivatives (PPDs) and topical cantharidin have not earlier been compared with their effectiveness in therapy Aim: The aim of this research was to determine the effectiveness and security of intralesional immunotherapy in the therapy of MC with tuberculin PPD versus topical cantharidin Patients and methods: Twenty patients with various MC lesions received topical cantharidin as control (group A) and 20 MC patients received intralesional tuberculin PPD following prior intradermal immunity tests (group B‏). Results: Complete clearance of lesions was detected in 90.0% of patients in the cantharidin group; the partial response was detected in10.0% of the patients. However, in the PPD group, 85% of the patients showed a complete response and 15% showed a partial response, with no significant difference in the clinical response between the two groups. Mild side effects were detected‏. Conclusion: The results suggest that intralesional PPD and topical cantharidin 0.7% are effective and safe treatment modalities, but benefits of intralesional PPD is being a simple, effective and safe treatment with tolerable pain and can be an alternative treatment for multiple resistant types‏.

Jacobsen syndrome is caused by a terminal deletion on the long arm of chromosome 11 and can be associated with immunodeficiency. Patients with Jacobsen syndrome can be predisposed to cutaneous viral infections that are difficult to treat. We report successful use of topical 1% cidofovir as treatment of recalcitrant verruca vulgaris in one patient and molluscum contagiosum in another patient with Jacobsen syndrome. Topical cidofovir appears to be a good treatment option in this cohort and should be considered early for treatment-resistant cutaneous viral infections., (© 2020 Wiley Periodicals LLC.)