Condition(s) treated: Severe Acne Vulgaris

Intervention: Adapalene BPO Gel associated with Doxycyline Hyclate (Drug); Vehicle Gel associated with Doxycycline Hyclate (Drug)

Phase: Phase 3

Enrollment status: Not yet recruiting

Sponsor: Galderma

Principal investigator(s) or official(s):
Linda Stein Gold, MD, Principal Investigator, Affiliation: Henry Ford Medical Center-New Center One, Detroit, MI

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

The purpose of this study is to demonstrate the efficacy of Adapalene 0. 1% / Benzoyl Peroxide 2. 5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0. 1% /Benzoyl Peroxide 2. 5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.

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

Primary outcome: Percent change from Baseline in total lesion count at Week 12 (Time Frame: Week 12)

Secondary outcome:
Percent change from Baseline in total lesion count at each intermediate visit, Percent change in inflammatory lesion count and in non-inflammatory lesion count at each post Baseline visit. (Time Frame: Weeks 2, 4, 8 and 12)

Incidence of Adverse Events, Local tolerance worst-score post Baseline, Postinflammatory hyperpigmentation for subjects with phototypes IV to VI (Time Frame: All along the study)

Investigator Global Assessment at each post Baseline visit, Global Improvement from Baseline at week 12/early termination (Time Frame: Weeks 2, 4, 8 and 12)

Detailed description: Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR. 29075)

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

Criteria:

Inclusion Criteria:

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

- Subjects with severe facial acne (global severity score of 4)

- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,

excluding the nose

- Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open

comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

- Subjects with more than 3 nodules or cysts on the face,

- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced

acne, etc.)

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

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

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