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NCT03427554 · ClinicalTrials.gov registry record · Early Phase 1
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris
A Early Phase 1 study, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 455
- Enrollment target
NCT03427554: Completed Early Phase 1 study, sponsored by Sun Pharmaceutical Industries.
NCT03427554 is a Early Phase 1 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 455 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (758% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03427554, a Early Phase 1 study, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 455 participants
- Enrollment target
Study Summary
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
Primary Outcome
Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts
Interventions
- DRUG Tretinoin cream 0.1%
- DRUG Vehicle of the test product
- DRUG RETIN-A® Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2017-08-21 |
| Est. Completion | 2018-01-26 |
| Phase | Early Phase 1 |
What the finished NCT03427554 record still lists
NCT03427554 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (758% higher).
The record links to 0 conditions, and to 3 interventions - of which Tretinoin cream 0.1% is the first listed.
NCT03427554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03427554 about?
NCT03427554 is a clinical study titled "To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris". Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
What is the current status of trial NCT03427554?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 455 participants. The study started on 2017-08-21. Estimated completion is 2018-01-26.
What interventions are being tested in trial NCT03427554?
The interventions under investigation include: Tretinoin cream 0.1% (DRUG), Vehicle of the test product (DRUG), RETIN-A® Cream (DRUG).
Who is sponsoring clinical trial NCT03427554?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03427554's enrollment target sits among peer trials
455 24th of 2000 higher than 1,977 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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