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NCT03717506 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
A Phase 3 study, sponsored by Balmoral Medical company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,236
- Enrollment target
NCT03717506: Completed Phase 3 study, sponsored by Balmoral Medical company.
NCT03717506 is a Phase 3 study that has completed, run by Balmoral Medical company. The registered enrollment target is 1,236 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03717506, a Phase 3 study, has completed, sponsored by Balmoral Medical company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,236 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
Primary Outcome
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Interventions
- DRUG GDC 268 Lotion
- DRUG Clindamycin Phosphate Lotion 1%
- DRUG GDC Vehicle Lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,236 participants |
| Start Date | 2018-10-10 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 3 |
What the finished NCT03717506 record still lists
NCT03717506 is an interventional study that assigns participants to a tested intervention. Its 1,236 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 3 interventions - of which GDC 268 Lotion is the first listed.
NCT03717506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03717506 about?
NCT03717506 is a clinical study titled "Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris". The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
What is the current status of trial NCT03717506?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,236 participants. The study started on 2018-10-10. Estimated completion is 2020-04-16.
What interventions are being tested in trial NCT03717506?
The interventions under investigation include: GDC 268 Lotion (DRUG), Clindamycin Phosphate Lotion 1% (DRUG), GDC Vehicle Lotion (DRUG).
Who is sponsoring clinical trial NCT03717506?
This trial is sponsored by Balmoral Medical company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03717506's enrollment target sits among peer trials
1,236 214th of 2000 higher than 1,787 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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