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NCT03433378 · ClinicalTrials.gov registry record · Early Phase 1

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% 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
700
Enrollment target

NCT03433378: Completed Early Phase 1 study, sponsored by Sun Pharmaceutical Industries.

NCT03433378 is a Early Phase 1 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 700 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (1221% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03433378, a Early Phase 1 study, has completed, sponsored by Sun Pharmaceutical Industries.

COMPLETED
Registry status
Early Phase 1
Development phase
700 participants
Enrollment target

Study Summary

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Primary Outcome

Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

Interventions

  • DRUG Vehicle of the test product
  • DRUG Tretinoin cream, 0.05%
  • DRUG RETIN-A® (tretinoin) cream, 0.05%

Trial Details

FieldValue
Enrollment Target 700 participants
Start Date 2017-08-04
Est. Completion 2018-01-26
Phase Early Phase 1
Sun Pharmaceutical Industries

48 total trials

What the finished NCT03433378 record still lists

NCT03433378 is an interventional study that assigns participants to a tested intervention. The registered 700 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 (1221% higher).

The record links to 0 conditions, and to 3 interventions - of which Vehicle of the test product is the first listed.

NCT03433378 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03433378 about?

NCT03433378 is a clinical study titled "To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris". Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

What is the current status of trial NCT03433378?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 700 participants. The study started on 2017-08-04. Estimated completion is 2018-01-26.

What interventions are being tested in trial NCT03433378?

The interventions under investigation include: Vehicle of the test product (DRUG), Tretinoin cream, 0.05% (DRUG), RETIN-A® (tretinoin) cream, 0.05% (DRUG).

Who is sponsoring clinical trial NCT03433378?

This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03433378's enrollment target sits among peer trials

700 15th of 2000 higher than 1,986 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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Source: ClinicalTrials.gov NCT03433378, the US trial registry maintained by the National Library of Medicine. NCT03433378 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.