Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

NCT00926367 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-05-20

Study results available
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Summary

This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product

Conditions

  • Acne Vulgaris

Interventions

DRUG

Clindamycin and benzoyl peroxide

Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel.

DRUG

benzoyl peroxide 2.5% and adapalene 0.1% gel

Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00926367 on ClinicalTrials.gov