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

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion; Drug: Adapalene BPO Gel standard daily overnight application; Drug: Adapalene-BPO 3-hour daily application before bedtime; Drug: Adapalene-BPO Gel every other day application

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883233

RD.03.SPR.29085

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 4 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Adapalene-BPO 3-hour daily application before bedtime

2

Experimental group

Description:

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

Treatment:

Drug: Adapalene-BPO Gel every other day application

3

Experimental group

Description:

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

Treatment:

Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion

4

Active Comparator group

Description:

Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week

Treatment:

Drug: Adapalene BPO Gel standard daily overnight application