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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 is a Phase 3 study that has completed, run by Novan. The registered enrollment target is 352 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03927716
The ClinicalTrials.gov registry entry for NCT03927716 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novan, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03927716 reports 0 study locations.
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.
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