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NCT03292640 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
A Phase 3 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 547
- Enrollment target
NCT03292640: Completed Phase 3 study, sponsored by Dr. Reddy's Laboratories Limited.
NCT03292640 is a Phase 3 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 547 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292640, a Phase 3 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 547 participants
- Enrollment target
Study Summary
Enrollment of subjects with mild to moderate facial acne vulgaris. Co-Primary efficacy endpoints included: * Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face * Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face * Proportion of subjects with a clinical response of "success" at Week 12 for lesions on the face. Success based on IGA is defined as an IGA score of 0 (Clear) or 1 (Almost clear) at Week 12 with at least a 2-grade reduction from Baseline.
Primary Outcome
Change in inflammatory lesion counts on the face from baseline to Week 12
Interventions
- DRUG DFD-03 (0.1% tazarotene) Lotion
- DRUG DFD-03 (0% tazarotene) Lotion (Placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2018-05-14 |
| Phase | Phase 3 |
What the finished NCT03292640 record still lists
NCT03292640 is an interventional study that assigns participants to a tested intervention. The registered 547 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 (29% lower).
The record links to 0 conditions, and to 2 interventions - of which DFD-03 (0.1% tazarotene) Lotion is the first listed.
NCT03292640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03292640 about?
NCT03292640 is a clinical study titled "A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks". Enrollment of subjects with mild to moderate facial acne vulgaris. Co-Primary efficacy endpoints included: * Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face * Absolute change from Baseline to Week 12 in the non-inflammatory lesion counts on the face * Proport...
What is the current status of trial NCT03292640?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2017-07-06. Estimated completion is 2018-05-14.
What interventions are being tested in trial NCT03292640?
The interventions under investigation include: DFD-03 (0.1% tazarotene) Lotion (DRUG), DFD-03 (0% tazarotene) Lotion (Placebo) (DRUG).
Who is sponsoring clinical trial NCT03292640?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03292640's enrollment target sits among peer trials
547 689th of 2000 higher than 1,312 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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