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NCT03927716 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
A Phase 3 study, sponsored by Novan.
- Completed
- Registry status
- Phase 3
- Development phase
- 352
- Enrollment target
NCT03927716: Completed Phase 3 study, sponsored by Novan.
NCT03927716 is a Phase 3 study that has completed, run by Novan. The registered enrollment target is 352 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03927716, a Phase 3 study, has completed, sponsored by Novan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 352 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 340 subjects ≥6 months of age with MC. Subjects or their caregivers will apply SB206 12% 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 Placebo
- DRUG SB206 12%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-01-29 |
| Phase | Phase 3 |
What the finished NCT03927716 record still lists
NCT03927716 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03927716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03927716 about?
NCT03927716 is a clinical study titled "A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)". This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 340 subjects ≥6 months of age with MC. Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to ...
What is the current status of trial NCT03927716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2019-06-03. Estimated completion is 2020-01-29.
What interventions are being tested in trial NCT03927716?
The interventions under investigation include: Placebo (DRUG), SB206 12% (DRUG).
Who is sponsoring clinical trial NCT03927716?
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 NCT03927716's enrollment target sits among peer trials
352 1030th of 2000 higher than 968 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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