Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance (ACCESS II)

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne

Treatments: Drug: Vehicle Gel; Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687908

RD.03.SPR.29075

Details and patient eligibility

About

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Full description

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Enrollment: 243 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Exclusion criteria

• Female Subjects who are pregnant, nursing or planning a pregnancy during the study
• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily

Treatment:

Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel

2

Placebo Comparator group

Description:

Vehicle Gel once daily

Treatment:

Drug: Vehicle Gel