Berdazimer gel 10.3 % found effective in clearing molluscum lesions in phase 3 SIMPLE clinical trial
United States: According to findings from phase 3 B-SIMPLE clinical trials, new data presented during the annual meeting of the American Academy of Dermatology (AAD) 2023, berdazimer gel 10.3 % will be the first potential drug by the US Food and Drug Administration (FDA) for molluscum in January 2024
It is already known that Berdazimer gel 10.3% is a topical nitric oxide for the management of molluscum contagiosum, a highly contagious viral infection of the skin in Phase 3 development.
Researchers have assessed the safety of berdazimer gel 10.3% in three phase 3 molluscum studies B-SIMPLE 1, 2 and 4.
Trial B-SIMPLE-1, 2 and 4 were randomized double-blind and evaluated the safety and efficacy of the application of berdazimer gel 10.3% once daily or vehicle gel for 12 weeks.
The researchers have included children of ≥6 months of age with a history of 3-70 molluscum lesions. They set Safety endpoints as the incidence of treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs).
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.