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

Launched by GALDERMA R&D · Nov 16, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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,

Trial Officials