The topical therapy has been under investigation as a first-in-class therapy for this highly contagious skin condition.
The topical formulation berdazimer gel, 10.3% demonstrated favorable efficacy and safety among patients with molluscum contagiosum (MC), according to phase 3 data from the randomized clinical trial, B-SIMPLE4.
Molluscum contagiosum is among the most contagious skin conditions, affecting roughly 6 million people affected by MC annually in the US, with the greatest incidence occurring in children 1-14 years old. Currently, no medications have been approved by the US Food and Drug Administration for this condition.
Berdazimer gel, 10.3% has been under investigation as a first-in-class therapy for MC, with a post hoc integrayed efficacy analysis of 2 phase 3 RCTs indicated complete clearance at week 12 in patients with MC with once-daily berdazimer gel versus placebo.
In this study, an investigative team led by John C. Browning, MD, MBA, of Texas Dermatology and Laser Specialists in San Antonio, provided efficacy and safety data from B-SIMPLE4, which featured patients 6 months and older with MC.
Eligible participants were culled from 55 sites across the US, with criteria excluding sexually transmitted MC in the periocular area and the inability to treat and count active lesions. Patients who received certain topical treatments or surgical procedures were also excluded from the study.
Following exclusions, eligible patients were randomized to either berdazimer gel, 10.3% or vehicle gel, both of which were applied to all lesions once daily for 12 weeks.
Of the 981 patients included in the study, 444 were randomized to the berdazimer group while 447 were assigned to the vehicle group. All patients were followed-up for 24 weeks, with study visits occurring at baseline/screening and weeks 2, 4, 8, 12, and 24.
The intention-to-treat (ITT) set featured all randomized patients.
Complete clearance of MC lesions at week 12 was the primary efficacy endpoint, and safety and tolerability related to adverse event frequency and severity.
By week 12 of the study, 88.5% and 88.8% of the berdazimer and vehicle group had lesion counts performed, respectively. By that week, a total of 144 patients (32.4%) in the berdazimer group achieved complete clearance of their lesions compared to 88 (19.7%) of patients in the vehicle group (P<.001).
Regarding discontinuation, 64 (14.4%) of patients in the berdazimer group discontinued treatment due to MC clearance compared with 40 (8.9%) patients in the vehicle group.
Adverse events were low, with the most common reactions being mild to moderate erythema. These events led to discontinuation for 18 (4.1%) patients in the berdazimer group and 3 patients (0.7%) in the vehicle group.
To the team’s knowledge, B-SIMPLE4 represented the largest RCT of medication for MC treatment. With berdazimer being considered for the first-in-class therapeutic option for MC, Browning and colleagues that, based on the data, the topical agent could “provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition.”
The study, "Efficacy and Safety of Topical Nitric Oxide−Releasing Berdazimer Gel in Patients With Molluscum ContagiosumA Phase 3 Randomized Clinical Trial," was published online in JAMA Dermatology.