Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

Official Title: “Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris”

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.

Intervention(s) in this Clinical Trial

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

• Percent change from Baseline in Total Lesion count
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• Investigator's Global Assessment at each post Baseline visit
  • Time Frame: Baseline, Week 2, Week 4, Week 8 and Week 12
    Safety Issue?: No

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 Investigator: Galderma Industry

Overall Clinical Trial Officials and Contacts

Florence Paliargues Study Director Galderma  

Information obtained from ClinicalTrials.gov on February 09, 2012

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