Berdazimer gel shows favorable molluscum contagiosum results in phase 3 study
Key takeaways:
- 30% of berdazimer gel-treated patients had complete clearance vs. 19.8% of vehicle-treated patients.
- If approved, berdazimer gel 10.3% will be the first at-home prescription medication for molluscum contagiosum.
NEW ORLEANS — A greater proportion of patients with molluscum contagiosum experienced complete clearance rates with berdazimer gel 10.3% vs. vehicle, according to a study presented at the American Academy of Dermatology Annual Meeting.
“Clinicians can know that a novel medication has been developed that is safe and effective in treating molluscum contagiosum,” John C. Browning, MD, FAAD, FAAP, of UT Health San Antonio, told Healio. “It can be used as a stand-alone topical medication or as adjunctive treatment following in-office destructive treatments.”
Browning presented results from the multicenter, randomized, double-blind, vehicle-controlled parallel trials from the B-SIMPLE phase 3 program evaluating the efficacy and safety of berdazimer gel 10.3% for the treatment of molluscum contagiosum (MC). The program, consisting of SIMPLE 1, 2 and 4, is the largest interventional cohort of patients with MC ever studied in phase 3, according to Browning.
The 1,598 patients were randomly assigned to receive berdazimer gel 10.3% (n = 917) or a vehicle (n = 681) once daily for 12 weeks.
Results showed that the study met the primary endpoint of a proportion of patients achieving complete clearance of all treatable MC lesions by week 12. The gel resulted in a greater complete clearance rate vs. vehicle (30% vs. 19.8%; OR = 1.753; 95% CI, 1.376-2.233).
Berdazimer was also superior to vehicle in achieving lesion rates of 0 or 1 at week 12, with 39.3% of berdazimer-treated patients seeing those results compared with 24.8% of vehicle-treated patients (OR = 2.062; 95% CI, 1.642-2.591).
Those aged 6 years to less than 12 years consistently performed higher than other groups, with 31.1% achieving complete clearance rates and 42.4% achieving 0 or 1 lesion rates compared with their vehicle counterparts (14% vs. 27.8%, respectively).
According to Browning, some patients saw results in as early as 2 weeks.
“This trial provides the necessary data to support the use of a novel topical medication in treating molluscum contagiosum,” Browning told Healio.
If approved by the FDA pending the review of a new drug application filed on Jan. 5, berdazimer gel 10.3% would be the first prescribed medication indicated for MC that could be applied by the patient or caregiver instead of by a provider in the office.
According to the presentation, the FDA prescription drug user fee act date is Jan. 5, 2024.