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NCT00964223 · ClinicalTrials.gov registry record · Phase 4

A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

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

Completed
Registry status
Phase 4
Development phase
28
Enrollment target

NCT00964223: Completed Phase 4 study, sponsored by Stiefel, a GSK Company.

NCT00964223 is a Phase 4 study that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00964223, a Phase 4 study, has completed, sponsored by Stiefel, a GSK Company.

COMPLETED
Registry status
Phase 4
Development phase
28 participants
Enrollment target

Study Summary

Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Primary Outcome

Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.

Interventions

  • DRUG Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
  • DRUG benzoyl peroxide and adapalene gel (EPIDUO™ Gel)

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2009-07
Est. Completion 2009-11
Phase Phase 4
Stiefel, a GSK Company

37 total trials

What the finished NCT00964223 record still lists

NCT00964223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) is the first listed.

NCT00964223 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00964223 about?

NCT00964223 is a clinical study titled "A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne". Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and r...

What is the current status of trial NCT00964223?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2009-07. Estimated completion is 2009-11.

What interventions are being tested in trial NCT00964223?

The interventions under investigation include: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel) (DRUG), benzoyl peroxide and adapalene gel (EPIDUO™ Gel) (DRUG).

Who is sponsoring clinical trial NCT00964223?

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 NCT00964223's enrollment target sits among peer trials

28 1635th of 2000 higher than 350 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 NCT00964223, the US trial registry maintained by the National Library of Medicine. NCT00964223 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.