Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Launched by GALDERMA R&D · Nov 17, 2011

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subject of any race, aged 12 to 35 years inclusive
• • 2. Subject weighing between 50 and 110 kg
• • 3. Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies)
• • 4. Subject with at least 5 nodules on the face
• Exclusion Criteria:
• • 1. Subject with clinically abnormal results to blood testings performed at screening
• • 2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks
• • 3. Female subject who is pregnant, nursing or planning a pregnancy during the study
• • 4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings
• • 5. Subject with known metabolic or structural bone disease (for 12-17 years old population)
• • 6. Subject with bowel disease and/or with hypervitaminosis A
• • 7. Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression
• • 8. Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months)
• • 9. Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)