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Efficacy and safety of CIP-isotretinoin in patients
with severe recalcitrant nodular acne.
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| 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 |
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| 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 |
| Gale Copyright: | Copyright 2009 Gale, Cengage Learning. All rights reserved. |