Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: adapalene gel, 0.3%; Drug: clindamycin/benzoyl peroxide gel

• Registration Number: NCT00671749
• Lead Sponsor: Galderma R&D

Brief Summary

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Detailed Description

Same as above.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2014-08-12
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-16
• Results First Posted: 2016-03-16
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects with a minimum of 20 inflammatory lesions on the face;
2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
3. Subject has a Global Severity Assessment

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Exclusion Criteria

1. Subjects with more than three nodulo-cystic lesions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Treatment	adapalene gel, 0.3%	adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning
Study Treatment	clindamycin/benzoyl peroxide gel	adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Lesion Counts	6 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Worst Post Baseline Tolerability Assessment - Erythema	12 weeks	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Global Severity Assessment Success	6 and 12 weeks	Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear
Worst Post Baseline Tolerability Assessment - Scaling	12 weeks	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Worst Post Baseline Tolerability Assessment - Dryness	12 weeks	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Worst Post Baseline Tolerability Assessment - Burning/Stinging	12 weeks	Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Global Assessment of Improvement From Baseline	12 weeks

Trial Locations

Locations (4)

Northwest Cutaneous Research Specialists; 🇺🇸 Portland, Oregon, United States

Brodell Medical; 🇺🇸 Warren, Ohio, United States

Derm Research, P.L.L.C.; 🇺🇸 Louisville, Kentucky, United States

Center for Dermatology and Laser Surgery; 🇺🇸 Sacramento, California, United States