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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 is a Phase 3 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 547 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03292640
The ClinicalTrials.gov registry entry for NCT03292640 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DFD-03 (0.1% tazarotene) Lotion is the first listed.
NCT03292640 reports 0 study locations.
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.
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