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NCT00964366 · ClinicalTrials.gov registry record · Phase 4

Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications

A Phase 4 study, sponsored by Stiefel, a GSK Company.

Completed
Registry status
Phase 4
Development phase
53
Enrollment target

NCT00964366: Completed Phase 4 study, sponsored by Stiefel, a GSK Company.

NCT00964366 is a Phase 4 study that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00964366, a Phase 4 study, has completed, sponsored by Stiefel, a GSK Company.

COMPLETED
Registry status
Phase 4
Development phase
53 participants
Enrollment target

Study Summary

This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control.

Primary Outcome

Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion

Interventions

  • DRUG clindamycin and benzoyl peroxide
  • DRUG Dapsone gel

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2009-07
Est. Completion 2009-08
Phase Phase 4
Stiefel, a GSK Company

37 total trials

What the finished NCT00964366 record still lists

NCT00964366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which clindamycin and benzoyl peroxide is the first listed.

NCT00964366 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00964366 about?

NCT00964366 is a clinical study titled "Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications". This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control.

What is the current status of trial NCT00964366?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2009-07. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00964366?

The interventions under investigation include: clindamycin and benzoyl peroxide (DRUG), Dapsone gel (DRUG).

Who is sponsoring clinical trial NCT00964366?

This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00964366's enrollment target sits among peer trials

53 1229th of 2000 higher than 768 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 NCT00964366, the US trial registry maintained by the National Library of Medicine. NCT00964366 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.