Efficacy and safety of CIP-isotretinoin in patients with severe recalcitrant nodular acne.
Article Type: Brief article
Subject: Isotretinoin (Dosage and administration)
Isotretinoin (Comparative analysis)
Acne (Drug therapy)
Acne (Patient outcomes)
Acne (Research)
Generic drugs (Dosage and administration)
Generic drugs (Comparative analysis)
Pub Date: 11/01/2009
Publication: Name: Journal of Drugs in Dermatology Publisher: Journal of Drugs in Dermatology, Inc. Audience: Academic; Trade Format: Magazine/Journal Subject: Health; Pharmaceuticals and cosmetics industries Copyright: COPYRIGHT 2009 Journal of Drugs in Dermatology, Inc. ISSN: 1545-9616
Issue: Date: Nov, 2009 Source Volume: 8 Source Issue: 11
Topic: Event Code: 310 Science & research
Product: Product Code: 2834012 Generic Drugs NAICS Code: 325412 Pharmaceutical Preparation Manufacturing SIC Code: 2834 Pharmaceutical preparations
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 213299780
Full Text: Sponsored by Cipher Pharmaceuticals, Inc. The purpose of this study is to compare the efficacy and safety of CIP-isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice-daily with meals.

Primary outcome measures will include: total nodular lesion count (facial and truncal) and proportion of patients who achieve at least a 90% reduction in total number of nodular lesions (facial and truncal). Secondary outcome measures will include: proportion of patients who are rated as clear/almost clear on the six-point Physicians' Global Assessment Scale.
Condition                           Intervention                Phase

Severe Nodular Acne  Drug: CIP-Isotretinoin and isotretinoin  Phase III

Study ID Numbers: ISOCT.08.01
ClinicalTrials.gov Identifier: NCT00975143
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