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

Acne Vulgaris Clinical Trial

Official title:

A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671749
• Other study ID #: US10066
• Status: Completed
• Phase: Phase 4
• Start date: December 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Same as above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

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

Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• adapalene gel, 0.3%
Applied once daily at bedtime
• clindamycin/benzoyl peroxide gel
Applied once daily in the morning

Locations

Country	Name	City	State
United States	Derm Research, P.L.L.C.	Louisville	Kentucky
United States	Northwest Cutaneous Research Specialists	Portland	Oregon
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	Brodell Medical	Warren	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Total Lesion Counts		6 and 12 weeks
Secondary	Global Severity Assessment Success	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	6 and 12 weeks
Secondary	Global Assessment of Improvement From Baseline		12 weeks
Secondary	Worst Post Baseline Tolerability Assessment - Erythema	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.	12 weeks
Secondary	Worst Post Baseline Tolerability Assessment - Scaling	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.	12 weeks
Secondary	Worst Post Baseline Tolerability Assessment - Dryness	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.	12 weeks
Secondary	Worst Post Baseline Tolerability Assessment - Burning/Stinging	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.	12 weeks