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NCT01182636 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 601
- Enrollment target
NCT01182636: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01182636 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 601 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (902% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01182636, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 601 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris.
Primary Outcome
Per Protocol Population (PPP) was assessed for the mean percent reduction compared to baseline in non-nodular lesion count (papules and pustules) at Day 84. If a patient was withdrawn from the study prior to Day 84 for lack of efficacy, then their data was carried forward for this analysis.
Interventions
- DRUG Placebo
- DRUG Adapalene
- DRUG Differin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
What the finished NCT01182636 record still lists
NCT01182636 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (902% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01182636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01182636 about?
NCT01182636 is a clinical study titled "Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris". The objective of this study was to evaluate the efficacy and safety of the test formulation of adapalene gel 0.1% (PLIVA Research \& Development Ltd.) as compared to the already marketed formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with acne vulgaris.
What is the current status of trial NCT01182636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 601 participants. The study started on 2007-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT01182636?
The interventions under investigation include: Placebo (DRUG), Adapalene (DRUG), Differin® (DRUG).
Who is sponsoring clinical trial NCT01182636?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01182636's enrollment target sits among peer trials
601 27th of 2000 higher than 1,974 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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