At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 891 enrolled
Drug / intervention
SB206 10.3% berdazimer +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy and Safety of SB206 and Vehicle Gel Once Daily in the Treatment of Molluscum Contagiosum
In Brief
A Phase 3 clinical trial evaluating SB206 10.3% berdazimer and vehicle gel for Molluscum Contagiosum. Completed, enrolled 891 participants across 55 sites.
Detailed Summary
This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMolluscum Contagiosum
CountriesUnited States
CollaboratorsTherapeutics, Inc., Synteract, Inc.
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedSep 2020
Primary CompletionApr 2021
Study CompletionJul 2021
TodayJul 2026
First PostedSep 2, 2020
Enrollment StartSep 1, 2020
Primary CompletionApr 28, 2021
Study CompletionJul 28, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago
Interventions
SB206 10.3% berdazimerdrug
Topically once daily
vehicle geldrug
Topically once daily