Condition(s) treated: Acne

Intervention: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel (Drug); Vehicle Gel (Drug)

Phase: Phase 3

Enrollment status: Not yet recruiting

Sponsor: Galderma

Principal investigator(s) or official(s):
Diane Thiboutot, MD, Principal Investigator, Affiliation: Penn State College of Medicine, Hershey, PA

Overall contact:
Jean-Charles Dhuin, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galderma.com

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.

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-Month Acne Maintenance Treatment

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Maintenance rate for total lesions at Week 24 : defined as the percentage of subjects maintaining at least 50% of the improvement obtained with prior combination therapy, in terms of total lesion counts. (Time Frame: Week 24)

Secondary outcome:
Maintenance rate for total lesions: at each intermediate visits, Maintenance rate for inflammatory lesions: at each post Baseline visit, Maintenance rate for non-inflammatory lesions: at each post Baseline visit (Time Frame: Weeks 4, 8, 12, 16, 20 and 24)

Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postiflammatory Hyperpigmentation Worst-score post Baseline. (Time Frame: All along the study)

Detailed description:

This study is a follow-up to RD. 03. SPR. 29074 - ACCESS I - "Adapalene-BPO Gel Associated With

Doxycycline 100 mg in the Treatement of Severe Acne Vulgaris"

Minimum eligible age: 12 Years. Maximum eligible age: 35 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who completed the previous study (RD. 03. SPR29074)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).

Jean-Charles Dhuin, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galderma.com

Start date: October 2008
End date: August 2009
Last updated: May 30, 2008

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