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NCT01138735 · ClinicalTrials.gov registry record · Phase 4

Epiduo Pediatric Acne Study

A Phase 4 study, sponsored by Galderma R&D.

Completed
Registry status
Phase 4
Development phase
285
Enrollment target

NCT01138735: Completed Phase 4 study, sponsored by Galderma R&D.

NCT01138735 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 285 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01138735, a Phase 4 study, has completed, sponsored by Galderma R&D.

COMPLETED
Registry status
Phase 4
Development phase
285 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Primary Outcome

Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)

Interventions

  • DRUG Topical Gel Vehicle
  • DRUG adapalene/benzoyl peroxide

Trial Details

FieldValue
Enrollment Target 285 participants
Start Date 2010-06
Est. Completion 2011-08
Phase Phase 4
Galderma R&D

158 total trials

What the finished NCT01138735 record still lists

NCT01138735 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).

The record links to 0 conditions, and to 2 interventions - of which Topical Gel Vehicle is the first listed.

NCT01138735 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01138735 about?

NCT01138735 is a clinical study titled "Epiduo Pediatric Acne Study". The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

What is the current status of trial NCT01138735?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 285 participants. The study started on 2010-06. Estimated completion is 2011-08.

What interventions are being tested in trial NCT01138735?

The interventions under investigation include: Topical Gel Vehicle (DRUG), adapalene/benzoyl peroxide (DRUG).

Who is sponsoring clinical trial NCT01138735?

This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01138735's enrollment target sits among peer trials

285 302nd of 2000 higher than 1,699 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01138735, the US trial registry maintained by the National Library of Medicine. NCT01138735 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.