Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

Acne Clinical Trial

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Official title:

Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883233
• Other study ID #: RD.03.SPR.29085
• Status: Completed
• Phase: Phase 3
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2010
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male or female Subjects of any race, aged 12 to 35 years inclusive

• Subjects with mild or moderate facial acne vulgaris

• Subjects with skin phototype I to IV

Exclusion Criteria:

• Subjects with more than 1 nodules or cysts on the face,

• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• Adapalene BPO Gel standard daily overnight application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
• Adapalene-BPO 3-hour daily application before bedtime
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
• Adapalene-BPO Gel every other day application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
• Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks

Locations

Country	Name	City	State
Canada	Galderma Investigational Site	Montreal	Quebec
Canada	Galderma Investigational Site	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.	Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.	Week 4

External Links

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