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NCT06733402 · ClinicalTrials.gov registry record · Phase 1
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris
A Phase 1 study of Acne Vulgaris, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,000
- Enrollment target
- 1
- Study location
NCT06733402: Completed Phase 1 study of Acne Vulgaris, sponsored by Sun Pharmaceutical Industries.
NCT06733402 is a Phase 1 study of Acne Vulgaris that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 1,000 participants, above the 260-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (285% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06733402, a Phase 1 study of Acne Vulgaris, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,000 participants
- Enrollment target
- 1
- Study location
Study Summary
To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
Primary Outcome
Percentage change in the inflammatory (papules and pustules) \& non-inflammatory (open and closed comedones) of the lesion counts.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Trifarotene Cream 0.005%
- DRUG AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG
- DRUG AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT
Study Locations (1)
New York
- Taro Pharmaceuticals USA Inc. - Hawthorne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2024-11-09 |
| Phase | Phase 1 |
What the finished NCT06733402 record still lists
NCT06733402 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 260-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (285% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06733402 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06733402 about?
NCT06733402 is a clinical study titled "A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris". To demonstrate the efficacy, therapeutic equivalence and safety of Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and US Reference Listed Drug, Canadian Reference Product over the placebo control in the treatment of acne vulgaris.
What is the current status of trial NCT06733402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,000 participants. The study started on 2024-06-20. Estimated completion is 2024-11-09.
What conditions does trial NCT06733402 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT06733402?
The interventions under investigation include: Placebo (DRUG), Trifarotene Cream 0.005% (DRUG), AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG (DRUG), AKLIEF® Cream (Trifarotene 50 mcg/g) CANADIAN REFERENCE PRODUCT (DRUG).
Who is sponsoring clinical trial NCT06733402?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06733402 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06733402's enrollment target sits among peer trials
1,000 2nd of 67 the highest of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris 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.
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