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NCT00599521 · ClinicalTrials.gov registry record · Phase 3

Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

A Phase 3 study, sponsored by Galderma R&D.

Completed
Registry status
Phase 3
Development phase
1,067
Enrollment target

NCT00599521: Completed Phase 3 study, sponsored by Galderma R&D.

NCT00599521 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 1,067 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00599521, a Phase 3 study, has completed, sponsored by Galderma R&D.

COMPLETED
Registry status
Phase 3
Development phase
1,067 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Primary Outcome

Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe.

Interventions

  • DRUG Adapalene lotion 0.1%
  • DRUG Adapalene Lotion Vehicle

Trial Details

FieldValue
Enrollment Target 1,067 participants
Start Date 2007-11
Est. Completion 2008-12
Phase Phase 3
Galderma R&D

158 total trials

What the finished NCT00599521 record still lists

NCT00599521 is an interventional study that assigns participants to a tested intervention. Its 1,067 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher).

The record links to 0 conditions, and to 2 interventions - of which Adapalene lotion 0.1% is the first listed.

NCT00599521 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00599521 about?

NCT00599521 is a clinical study titled "Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%". The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

What is the current status of trial NCT00599521?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,067 participants. The study started on 2007-11. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00599521?

The interventions under investigation include: Adapalene lotion 0.1% (DRUG), Adapalene Lotion Vehicle (DRUG).

Who is sponsoring clinical trial NCT00599521?

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 NCT00599521's enrollment target sits among peer trials

1,067 274th of 2000 higher than 1,727 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00599521, the US trial registry maintained by the National Library of Medicine. NCT00599521 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.