Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Drug: Adapalene 0.1% / BPO 2.5% gel with Lymecycline (Tetralysal) capsules
  • Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning
• Drug: Adapalene 0.1% / BPO 2.5% vehicle gel with Lymecycline (Tetralysal) capsules
  • Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Adapalene 0.1% / BPO 2.5% gel
• Placebo Comparator: Adapalene 0.1% / BPO 2.5% Vehicle Gel

Primary Measures

• Non-Inflammatory Lesions and Inflammatory Lesions, nodules/cysts counts on the face (excluding the nose)
  • Time Frame: Five study visits will be performed: Baseline, Week 2, Week 4, Week 8 and Week 12. (12-week study) . A screening visit will be performed in Germany (6 visits - 14 weeks)
    
• Investigator's Global Assessment: severity of acne on a scale from 0 to 5
  • Time Frame: Five study visits will be performed: Baseline, Week 2, Week 4, Week 8 and Week 12. (12-week study) . A screening visit will be performed in Germany (6 visits - 14 weeks)
    

Inclusion Criteria:

• 1. Male or female Subjects of any race, aged 12 to 35 years inclusive, 2. Subjects with moderate to severe facial acne vulgaris (Investigator's Global
• Assessment score of 3 or 4),

Exclusion Criteria:

• 1. Subjects with more than 3 nodules or cysts on the face
• 2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. Subjects with a wash-out period for topical treatment on the face less than:
• Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks), Zinc containing drugs (1 week), Phototherapy devices for acne and cosmetic procedures (1 week)
• 4. Subjects with a wash-out period for systemic treatment less than:Acne therapy containing zinc (4 weeks), Corticosteroids, antibiotics (4 weeks), Other acne treatments (6 months), Ciproterone acetate / Chlormadinone acetate (6 months), Spironolactone / Drospirenone (3 months)
• 5. Subjects with impaired hepatic (ALT/AST > 3xULN and bilirubin > 1.5xULN) or renal (creatinine clearance greater than 60 ml/min) functions based on a blood sample, 6. Subjects with known intolerance to lactose,

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma

Overall Clinical Trial Officials and Contacts

Overall Contact: Florence PALIARGUES +33492952957 

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01014689

Study ID Number: RD.03.SPR.29080

ClinicalTrials.gov Identifier: NCT01014689

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products