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NCT04535531 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
A Phase 3 study, sponsored by Novan.
- Completed
- Registry status
- Phase 3
- Development phase
- 891
- Enrollment target
NCT04535531: Completed Phase 3 study, sponsored by Novan.
NCT04535531 is a Phase 3 study that has completed, run by Novan. The registered enrollment target is 891 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04535531, a Phase 3 study, has completed, sponsored by Novan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 891 participants
- Enrollment target
Study 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.
Primary Outcome
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).
Interventions
- DRUG vehicle gel
- DRUG SB206 10.3% berdazimer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 891 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2021-07-28 |
| Phase | Phase 3 |
What the finished NCT04535531 record still lists
NCT04535531 is an interventional study that assigns participants to a tested intervention. The registered 891 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which vehicle gel is the first listed.
NCT04535531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04535531 about?
NCT04535531 is a clinical study titled "A Phase 3 Molluscum Contagiosum Efficacy and Safety Study". 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 minimu...
What is the current status of trial NCT04535531?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 891 participants. The study started on 2020-09-01. Estimated completion is 2021-07-28.
What interventions are being tested in trial NCT04535531?
The interventions under investigation include: vehicle gel (DRUG), SB206 10.3% berdazimer (DRUG).
Who is sponsoring clinical trial NCT04535531?
This trial is sponsored by Novan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04535531's enrollment target sits among peer trials
891 364th of 2000 higher than 1,637 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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