Berdazimer gel, a novel topical nitric oxide-releasing agent, was safe and effective as a treatment for molluscum contagiosum, according to findings from a multicenter, double-blind, phase 3 randomized clinical trial published in JAMA Dermatology.
Investigators conducted the B-SIMPLE4 trial, a phase 3 study designed to confirm the efficacy and safety of topical berdazimer gel 10.3% compared with vehicle (1:1) when applied once daily for up to 12 weeks in patients aged 6 months or older with molluscum contagiosum (MC). Patients’ treatment period ended when all lesions cleared; patients were followed for recurrence or new lesion appearances until week 24. Patients with 3 to 70 MC lesions at baseline were included, and those with sexually transmitted MC or MC limited to the periocular area were excluded.
Investigators conducted an efficacy analysis using logistic regression on the intention-to-treat (ITT) group, which included all randomly assigned patients, and a safety analysis on the safety group that included all patients who received at least 1 application of berdazimer gel 10.3%. The primary efficacy endpoint was the difference in percentage of patients assigned berdazimer and vehicle patients who achieved complete clearance by week 12, researchers wrote; the safety endpoints were adverse events and local skin reactions through week 12 and scarring through week 24.
There were 891 patients included in the analysis: 444 randomly assigned to berdazimer, with a mean age of 6.6 (range, 0.9-47.5) years, 51.4% men, and 447 randomly assigned to vehicle, with a mean age of 6.5 (range, 1.3-49) years and 52.3%women. The majority (>80%) of patients in both groups were White.
In the berdazimer group, 32.4% achieved complete clearance by week 12, compared with 19.7% of patients in the vehicle group (odds ratio [OR], 2.0; 95% CI, 1.5-2.8; P <.001). There were 193 patients (43.5%) in the berdazimer group compared with 110 patients (24.6%) in the vehicle group who had a lesion count of 0 or 1 by week 12. In addition, 43.0% of patients given berdazimer vs 23.9% of patients given vehicle had a lesion reduction of 90% from baseline by week 12 (OR, 2.4; 95% CI, 1.8-3.3; P <.001). Throughout the study, a mixed-model repeated measures analysis of the least-squares mean percent change from baseline lesion count showed a greater lesion reduction for berdazimer vs vehicle, starting as early as week 2 and continuing through week 12.
Berdazimer was well-tolerated overall, demonstrated by a low adverse event-related discontinuation rate and treatment-emergent adverse events (TEAEs) that were mostly mild or moderate. At least 1 TEAE was reported by 43.0% of patients in the berdazimer group and 23.0% of the vehicle group, with 5 patients in the berdazimer group reporting severe TEAEs that were mostly application-site related events such as pain, erythema and dermatitis. No patients in either group reported keloidal or hypertrophic scars.
The study was limited by the study’s short follow-up period.
Currently, there is no FDA-approved treatment for MC and patients need to attend multiple in-office visits for eradication therapies which can often be painful. “Complete clearance at week 12 is a rigorous end point” for berdazimer, the study authors wrote, adding that the treatment’s demonstrated efficacy in reducing mean lesion count by week 4 “would likely be perceived by patients and caregivers as meaningful and would encourage them to maintain compliance with the prescribed 12-week therapy.”
Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: A phase 3 randomized clinical trial. JAMA Dermatol. Published online July 13, 2022. doi:10.1001/jamadermatol.2022.2721