Priyenka Khatiwada, BS1 and Mariana Phillips, MD1,2
1Virginia Tech Carilion School of Medicine, Roanoke, VA, USA
2Carilion Clinic Dermatology and Mohs Surgery, Roanoke, VA, USA

Conflicts of interest: The authors declare that there are no conflicts of interest. Funding sources: None.

ABSTRACT
Molluscum contagiosum (MC) is a cutaneous viral infection characterized by umbilicated, dome shaped papules. Although most lesions resolve spontaneously, treatment may be considered for symptomatic lesions or those causing cosmetic concerns. Until recently, off-label treatments were employed to hasten lesion clearance, including mechanical destruction or extraction, topical agents, and laser therapy. Recently, the United Stated Food and Drug Administration approved two agents for the treatment of MC, cantharidin 0.7% drug-device applicator and berdazimer 10.3% gel. Both agents have expanded the evidence-based treatment of MC. This review summarizes treatment of MC with special attention to these newly approved modalities.

Keywords: molluscum contagiosum, cantharidin, berdazimer, pulsed dye laser, Cochrane Review

Introduction

Molluscum contagiosum (MC) is a common cutaneous viral infection that presents as small umbilicated, pink to purple, dome-shaped papules. The condition is caused by the molluscum contagiosum virus (MCV), a double-stranded DNA virus within the Poxviridae family.1 The virus spreads through direct skin-to-skin contact or through fomites like toys and towels. The incubation period ranges from 2 to 6 weeks prior to onset of papules.2,3 Infections most commonly occur in children (predominantly between 1 to 4 years of age), sexually active young adults, and immunosuppressed individuals.4 There is a 5% prevalence in the pediatric population under 14 years of age, a 5-8% prevalence in patients with the Human Immunodeficiency Virus (HIV), and up to a 33.3% prevalence in late stage Acquired Immunodeficiency Syndrome (AIDS).5-7

In children, the face, trunk, and limbs are commonly affected sites, and lesions vary in number from a few to a hundred or more. Individual papules range in size from 3 to 5 mm. Multiple papules often present simultaneously, and most lesions heal spontaneously within 2 to 4 months. The duration of infection is usually 2 years.4 Patients with abnormal T-cell immunity, including atopic dermatitis, sarcoid, and HIV, may develop severe, atypical MC infections. Patients with atopic dermatitis may develop many lesions that are confined to the affected eczematous skin. In the case of HIV, lesions are often large (>15 mm), the surface may be hyperkeratotic, verrucous, or ulcerative, and widespread involvement including facial distribution is common.8,9

There are four strains of MCV with MCV-1 being the most prevalent among the pediatric population (98% of cases) and MCV-2 mainly affecting immunocompromised individuals (60% of cases).2,3 MCV-3 and MCV-4 can cause papular lesions, however, these strains rarely cause infections. The virus replicates within the cytoplasm of keratinocytes and produces immune-modulating proteins that suppress the host’s innate and acquired immune responses, promoting cell survival and apoptosis evasion.10 Specifically, the virus encodes proteins which prevent apoptosis and innate immune activation by inhibiting NF-κβ signaling, pro-inflammatory cytokine production, MHC Class 1 expression, and regional recruitment of NK- and T-cells.11-15

Lesions on the genitals, anus, lower abdomen, and inner thighs may be sexually transmitted, but this is not always the case. Autoinoculation is common and may account for lesions in these areas. Genital lesions may be seen in up to 10% of childhood cases and occur in association with a more widespread eruption.4 Sexual abuse should be considered when lesions are isolated to the genital area.7 In adults with genital lesions, screening for other sexually transmitted disease is recommended. Mucosal lesions occur rarely and may suggest underlying T-cell immunosuppression.4

Treatment for MC is contingent upon multiple factors including age, location of lesions, and immune status. For immunocompetent children and adults, the lesions will spontaneously resolve in months to years, however, the patient may desire treatment if lesions are causing symptoms, such as pruritus or secondary infections from scratching, or for cosmetic and social concerns.16 This review examines the treatment of MC, focusing on prospective comparative studies, randomized control trials (RCTs), and case series published after 2010, with particular attention to the two agents that were recently approved by the United States Food and Drug Administration (FDA): a single use proprietary drug-device combination containing cantharidin 0.7%(Ycanth®) and berdazimer 10.3% gel (Zelsuvmi™).

New Topical Treatment Modalities

Cantharidin

Cantharidin, an extract from blister beetles, is a potent inhibitor of protein phosphatases types 1 and 2A that promotes cell lysis of infected keratinocytes, resulting in vesiculation and bulla formation at the site of topical application. Cantharidin has been used off-label for years, often compounded with other agents like salicylic acid (keratolytic) and podophyllotoxin (cytotoxic) for synergistic activity against MC.17 The topical vesicant is applied directly to individual lesions in a physician’s office, and an occlusive dressing may be used but is not necessary. Typically, the patient is instructed to wash affected areas with soap and water 2-4 hours after application. Treatment can be repeated every 2-3 weeks until complete resolution is achieved.18

In July 2023, the FDA approved a drug-device combination containing 0.7% cantharidin to treat MC in patients ≥2 years of age. The formulation is applied by health care professionals utilizing a single use applicator that has a small opening at the tip allowing for controlled application of the film-forming solution to each lesion. Additionally, there is a coloring agent (gentian violet) mixed into the formulation that marks treated lesions to prevent repeat application. Patients are instructed to wash the treated areas with soap and water 24 hours after application.19

In a Phase 2 clinical trial, 33 patients were recruited for treatment with the proprietary cantharidin 0.7% drug-device applicator.20 Inclusion criteria included patients from 2-15 years of age, with visible MC lesions, and no significant medical history. Patients with molluscum venereum, molluscum eczema, immunosuppression, or recent previous molluscum treatments were excluded. The average age was 6.7 years. The treatment was applied every 21 days until complete lesion clearance or for a maximum of 4 treatments (12 weeks), whichever occurred first. Before each treatment application, all MC lesions were counted by a study investigator.

An average of 50.4% reduction in MC lesions from baseline was seen at 21 days. By 12 weeks, 90.4% of patients experienced a reduction in lesion count and 48.5% of patients achieved complete clearance. In patients with >21 lesions who were treated with a maximum of two applicators (n=66), systemic absorption of cantharidin was calculated. A detectable level of cantharidin (3.4 ng/mL) was noted at the 2-hour timepoint in a 2-year-old boy in whom 32 lesions had been treated. The measurements were below the lower limit of quantitation (LLOQ = 2.5 ng/mL) at the 6-hour and 24-hour timepoints. This child did not experience any systemic adverse events (AEs) indicative of cantharidin absorption. The remaining plasma samples were all below the LLOQ, and no AEs suggesting systemic toxicity were reported.20

Two Phase 3, randomized, double-blind, vehicle-controlled trials (n=528) of identical design enrolling children and adults (ages 2-60 years) were conducted in 31 centers across the US.21 Inclusion criteria for Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2] trials included age ≥2 years, a clinical diagnosis of MC, and status as otherwise healthy. Exclusion criteria included patients receiving any treatment in the previous 14 days, immunosuppression (HIV/AIDS or receiving immunosuppressant agents), or lesions within 10 mm of a mucosal site. The average ages for CAMP-1 and CAMP-2 participants were 7.5 and 7.4 years, respectively. Atopic dermatitis was reported in 16.1% (85/527) of participants. The patients were treated with the proprietary cantharidin 0.7% drug-device applicator every 21 days until complete lesion clearance or for a maximum of 4 treatments, whichever came first. The primary endpoint was complete clearance of all MC lesions by 12 weeks.

Across both Phase 3 CAMP trials, treatment with the cantharidin 0.7% drug-device applicator resulted in significantly higher rates of complete MC lesion clearance at week 12 compared with vehicle.21 In CAMP-1, complete clearance was achieved in 46.3% of patients treated with the cantharidin 0.7% drug-device vs. 17.9% of those receiving vehicle, while corresponding rates in CAMP-2 were 54.0% and 13.4%, respectively (both p<0.001).

Secondary analyses demonstrated significantly greater reductions in lesion counts with the cantharidin 0.7% drug-device compared with vehicle, with mean decreases of 69% and 83% in CAMP-1 and CAMP-2, vs. a 20% increase and 19% decrease in the vehicle groups, respectively (both p<0.05). Additionally, at each study visit, the percent of patients achieving complete clearance was higher in the treatment group compared with the vehicle group. Finally, at least one AE was reported by more than 94% of participants across treatment groups which were expected due to the nature of cantharidin being a vesicant. The most frequent AEs reported were application site vesicles, pain, pruritus, erythema, and scab (Table 1).21

Table 1:Molluscum Contagiosum: A Review and Update on New Treatments - image

Berdazimer

In January 2024, the FDA approved berdazimer 10.3% gel for treatment of MC in individuals aged ≥1 year. Coadministration of berdazimer gel and hydrogel results in the release of nitric oxide which has broad spectrum antiviral and antimicrobial activity. Nitric oxide reduces viral replication through the S-nitrosylation of viral proteins and reduces viral expression of proteins responsible for immune evasion.22,23 The proprietary product, containing one tube of berdazimer 10.3% gel and one tube of hydrogel, is self-administered by patients at home. Equal amounts of the two agents are mixed and applied daily to individual MC lesions. Treatment is most effective when allowed to fully dry for 10 minutes and left on 1 hour prior to swimming or bathing. Unlike other treatments, berdazimer does not have to be washed off.24

FDA approval was based on three RCT Phase 3 trials, Berdazimer Sodium In Molluscum Patients with LEsions (B-SIMPLE) 1, 2, and 4. B-SIMPLE 1 and 2 showed a positive trend towards complete clearance at week 12 (primary endpoint), but did not achieve statistical significance, therefore, B-SIMPLE 4 was conducted as the pivotal study.23 A secondary analysis pooling these three trials resulted in a collective sample size of berdazimer (n=917) vs. vehicle applicator (n=681).23 Inclusion criteria included patient age >6 months with 3 to 70 MC lesions. Immunosuppressed patients or those in whom MC lesions that were thought to be sexually transmitted were excluded. The average pooled treatment group age was 6.7 years. Patients were instructed to apply the study medication daily for up to 12 weeks. The primary endpoint, complete clearance at week 12, was observed in 30.1% and 20.1% of the berdazimer and vehicle groups, respectively (p<0.001). The secondary endpoint, partial clearance rates of ≥90% at week 12, was achieved for 38.6% and 23.3% of the treatment and vehicle groups, respectively (p<0.001). Clearance >75% at week 12 was achieved for 48.4% and 31.8% of the treatment and vehicle groups, respectively (p<0.001). Subgroup analysis showed the most favorable efficacy in male sex, patients 6 to 12 years of age, and those in whom the baseline lesion count <20. The difference between treatment and vehicle was not statistically significant for participants 2 to <6 years or 12 to <18 years of age. Furthermore, subgroup analysis of Black or African American participants was not statistically significant compared to vehicle, most likely due to small sample size. Lastly, participants who had >20 lesions treated, or a history of atopic dermatitis, also showed no statistically significant difference compared to vehicle.23 The most frequent AEs were application-site pain (18.7% vs. 4.8% berdazimer vs. vehicle) and erythema (11.7% vs. 1.3%) and were graded as mild to moderate in the majority of patients. Only 1.7% of participants treated with berdazimer experienced a severe AE.23

Cochrane Review (2017)

A Cochrane Review (2017) that assessed interventions for MC across 22 RCTs did not find a single most effective treatment for MC.25 The review noted that the study quality was low with high drop-out rates, and there was a lack of high quality RCTs for common treatments like curettage or topical hydrogen peroxide.25

Tretinoin

Tretinoin 0.1% cream has been used off-label to treat MC lesions at home. Tretinoin promotes keratinocyte turn over, but the exact mechanism of action is unknown. While a comparative study showed that tretinoin applied twice a day could help reduce molluscum lesions by 76%, potassium hydroxide reduced lesions by 82.4% and more quickly.26 Beyond, these results, no other high-quality studies have been conducted since 2010, and the Cochrane Review found little evidence to support its efficacy.25 While tretinoin can be used as an adjunct treatment option, more effective medications are available to treat MC.

Potassium Hydroxide

Potassium hydroxide (KOH) dissolves the keratin in MC lesions, which results in lesion clearance by direct destruction and secondary inflammation.17 KOH, 5% and 10% solutions, can be used to treat MC, however, the 10% solution is more frequently employed.25 KOH can be applied in the office by a provider or at home, with some studies instructing patients to apply KOH twice daily to individual lesions until signs of inflammation appear.26-28 KOH has been extensively investigated in small comparative studies with tretinoin, salicylic acid, and curettage, and KOH has consistently shown to completely resolve MC lesions in 64-87% of patients, working quickly within 4-9.8 weeks.26-36 While skin irritation and blistering have been reported, these side effects usually resolve within 2-3 days. KOH has been associated with permanent hypopigmentation at sites of application.32,35

Salicylic Acid

Salicylic acid (SA) functions as a keratolytic agent, effectively breaking down thickened skin cells of MC lesions, and triggering a secondary inflammatory response which results in further virus clearing.37 In contrast to other treatment options, 17% and 40% SA are available over-the-counter. There have been few high-quality studies to assess the efficacy of SA in MC.

A clinical trial of 70 patients randomized in a 1:1 ratio to daily, at home, application of 10% KOH (n=39) or 10% salicylic acid pomade (n=31) showed complete resolution at 8 weeks in 79.5% and 22.6% of the patients treated with KOH and SA pomade, respectively (p<0.01). AEs such as burning (76.9% vs. 19.4%), erythema (59% vs. 14%), and itching (17.9% vs. 16.1%) were more commonly observed in the KOH group compared to SA group.36

Lastly, the combination of SA and lactic acid (LA) has been shown to improve lesion clearance. A 2013 study showed that 100% of patients (n=14) treated with compounded SA and LA experienced complete resolution of MC lesions in 6 weeks.29

Imiquimod

Imiquimod is a Toll-like receptor 7 agonist that activates the innate and adaptive immune systems and induces apoptosis in atypical cells.10 The Cochrane Review reported that 5% imiquimod was ineffective, showing no benefit compared to vehicle/placebo, and caused more harm than placebo.25 These findings led the Centers for Disease Control and Prevention and the American Academy of Dermatology to update their guidance against using imiquimod for MC. A study comparing 0.015% ingenol mebutate (n=10) applied daily for 3 consecutive days per week until lesion clearance with 5% imiquimod (n=9) applied once daily, 5 times per week, found statistically significant (p<0.05) fewer lesion counts in the ingenol mebutate group at 2, 4, 8 and 12 weeks. At week 12, 90% and 33.3% of subjects showed complete clearance in the ingenol mebutate and imiquimod groups, respectively.38 Ingenol mebutate was initially marketed for actinic keratoses and has been voluntarily withdrawn from the market due to safety concerns.

Oral Cimetidine

Cimetidine enhances cell-mediated immunity by blocking histamine-driven activation of T-suppressor cells which has been thought to play a role in MC virus clearance. The literature addressing the utility of oral cimetidine in MC treatment is sparse, but the 2017 Cochrane Review included one RCT of 38 patients which showed no statistical difference in complete clearance of MC lesions with cimetidine (35 mg/kg/day) vs. placebo after 4 months of treatment.25

Physical Treatment Modalities

Liquid nitrogen, cryotherapy, pulsed dye laser, and curettage are destructive modalities widely employed to treat MC. Cryotherapy can be applied using spray or cryoprobe methods. A typical protocol involves applying liquid nitrogen for 5-10 seconds in 1 or 2 freeze-thaw cycles at each MC lesion repeated weekly.37

In a comparative study involving 74 children (2-12 years of age), patients were randomized to 5% imiquimod (n=37) applied 5 days per week vs. cryotherapy weekly (n=37). Complete clearance was achieved in 70% after 3 weeks of weekly cryotherapy vs. 2.7% of the imiquimod group. All patients were cleared with 6 weeks of weekly cryotherapy treatment vs. 59.45% of the imiquimod group. The weighted average of weekly cryotherapy treatment sessions required to achieve complete clearance for all patients was 3.89 weeks.39 In addition to the expected pain and blistering, the risk of erythema, permanent hypopigmentation, and scarring can make administration to a young child difficult.25 Cryotherapy remains an effective means of treating MC and ideal for treating large solitary lesions or few localized lesions.1

Curettage is a mechanical destructive procedure in which a curette is utilized to remove the central core of MC lesions. It has been shown to reduce scarring compared to cryotherapy, but it still carries the risk of post-inflammatory pigment alteration.17 An open-label study (n=50) has shown comparable MC clearance rates for 10% KOH
twice daily, 14% SA combined with 14% LA in collodion once daily, and single session curettage at 12 weeks.27

Pulsed dye laser (PDL) light (585-595 nm) is absorbed by hemoglobin and results in thermal damage to the vasculature. By damaging the microvasculature of the MC lesions, PDL accelerates resolution of the papules.40 Topical anesthesia or cryogen spray can be applied to minimize discomfort and often PDL is more tolerable than other means of physical destruction, particularly in the pediatric population.41 Reported treatment parameters typically include fluences of approximately 4-10 J/cm², pulse durations of 0.25-0.45 ms, and spot sizes of 3-10 mm, with 1-2 pulses applied to each lesion. Purpura serves as a clinical endpoint.42 A prospective case series with 15 children (3-5 years of age) demonstrated 100% lesion clearance after one PDL treatment session. This case series used a single pulse from a 585 nm PDL applied to each lesion (3 mm spot size, 300 ms pulse duration, 8.0 J/cm2).40 Most common AEs reported with PDL include transient erythema, purpura, and temporary hypo- or hyper-pigmentation.40 In difficult to treat MC, especially for patients with AIDS, or prolonged MC refractory to other treatments, PDL offers an effective option.7,8

Over-the-Counter Products

Over-the-counter (OTC) options for MC are commonly employed by patients hoping to avoid painful office procedures, frequent doctor’s visits, or those desiring natural treatments. Commonly utilized agents include proprietary products containing tea tree oil (TTO) or apple cider vinegar. Rationale for use exploits the proposed antiseptic and antiviral properties of TTO and the acidic properties of apple cider vinegar which are thought to be antimicrobial. A comparative study showed that 3 of 18 children (17%) treated with TTO alone compared with 16 of 19 children (84%) treated with TTO with organically bound iodine achieved a 90% reduction in MC lesions (p<0.01).43 ZymaDerm™ (a proprietary product containing TTO with organically bound iodine and other essential oils) is available OTC.

Discussion

Since 2023, the FDA has expanded treatment options for MC to include a cantharidin 0.7% drug-device applicator and berdazimer gel. Berdazimer gel offers the convenience of at home application. The AEs of cantharidin and berdazimer are similar and include mild local skin reactions (Table 1). Unfortunately, these agents have not been studied in immunocompromised patients, and there have not been any head-to-head comparisons between the two agents.

Physical destruction and cryotherapy are effective, but they run the risk of scarring and pigmentary changes. For MC refractory to other treatments, PDL and KOH may be effective, but AEs such as application pain and pigment alterations must be weighed against potential benefits.

The literature does not support the use of imiquimod. Physical treatment modalities are more often employed in patients with atopic dermatitis as the topical agents may be irritating and flare the underlying dermatitis. When molluscum lesions occur in areas of preexisting dermatitis, the weakest potency topical steroid to control the dermatitis should be prescribed.4

Immunocompromised patients can present with atypical MC lesions that can be challenging to treat. In the case of HIV/AIDS patients, strict adherence to antiretroviral treatment should be supported as many lesions dissolve with restoration of T-helper cell counts, although an initial flaring of lesions may be noted as part of the immure restoration syndrome.4

Most studies compiled in this review have a small sample size, and evidence supporting some interventions consists only of case studies and case series. Additionally, patients with atopic dermatitis or other dermatologic comorbidities were variably represented throughout each study, with multiple studies excluding patients with sexually transmitted MC and immunocompromised patients.

The recent FDA approval of two new treatments for MC is exciting. The available data shows that they are both efficacious and well-tolerated, although their efficacy for higher-risk populations such as comorbid atopic dermatitis or immunosuppression is less-certain. While the new treatments offer significant clinical advantages, their use may be limited by cost and availability. Future studies investigating these and other treatment modalities will serve to guide clinicians to the best evidence-based practice.

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STL Volume 31 Number 4
STL Volume 31 Number 4

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