Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT00160394|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Duac® Gel / Differin® Gel||Phase 4|
Title: A Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Duac® Gel (a Gel Containing Clindamycin Phosphate [Equivalent to 1% Clindamycin] and 5% Benzoyl Peroxide) And Differin® Gel (a Gel Containing 0.1% Adapalene) in the Topical Treatment of Mild to Moderate Acne Vulgaris
Objectives: To compare the efficacy and safety of a gel formulation containing a combination of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to moderate severity.
Study methodology: Randomised, comparator-controlled, single-blind trial. The Investigators/ Assessors will be blinded to the treatment received.
Study population: Male and female patients, aged 12-39, with mild to moderate acne vulgaris.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Duac® Gel And Differin® Gel in the Topical Treatment of Mild to Moderate Acne Vulgaris|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
- Percentage change from baseline of inflammatory lesion counts at week 2
- Absolute change from baseline of inflammatory lesion counts at week 2.
- Absolute change and percentage change from baseline of inflammatory lesion counts at weeks 1, 4, 8 and 12.
- Absolute change and percentage change from baseline of non-inflammatory lesion counts and total lesion counts at weeks 1, 2, 4, 8 and 12.
- Also, acne grade and global change score at weeks 1, 2, 4, 8 and 12 will be investigated.
- Patient's self-rating assessment at weeks 1, 2, 4, 8 and 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160394
|Prof A Langner|
|Warsaw, Poland, 00710|
|Dr V Goulden|
|Leeds, United Kingdom, LS1 3EX|
|Dr A Chu|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||A Chu, MB BS, FRCP||Hammersmith Hospital, London|
|Principal Investigator:||A Langner, MD, DSc||Iwolang spoo, Warsaw|