A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne
| Autor: | Graeme F. Bryce, John Arthur Mclane, Lynn A. Drake, Douglas Eberhardt, P. Harry L. Roth, Eduardo Tschen, Daniel Stewart, Eileen E. Leach, Dan K. Chalker, James J. Leyden, Lawrence K. Chang, Michael Jarratt, Anne W. Lucky, Irving Katz, Ronald P. Savin, Jon M. Hanifin, Nicholas J. Lowe, Elyse S. Rafal, David M. Pariser, Donald P. Lookingbill, Steven Kempers, Joseph J. Hong, John S. Strauss, David J. Baginski, Terry M. Jones, Robert J. Pariser |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.drug_class medicine.medical_treatment Biological Availability Dermatology Drug Administration Schedule Dosage form law.invention Double-Blind Method Randomized controlled trial law Acne Vulgaris medicine Humans In patient Retinoid Child Isotretinoin skin and connective tissue diseases Dosage Forms Chemotherapy business.industry Middle Aged Clinical trial Female Nodular acne business Tablets medicine.drug |
| Zdroj: | Journal of the American Academy of Dermatology. 45:187-195 |
| ISSN: | 0190-9622 |
| DOI: | 10.1067/mjd.2001.115965 |
| Popis: | Background: Isotretinoin is very frequently the drug of choice for the management of severe recalcitrant nodular acne. Recently, a new micronized and more bioavailable formulation of isotretinoin has been developed that permits once-daily administration in lower doses than usually used with standard isotretinoin (Accutane), regardless of whether it is taken with or without food. Objective: Our purpose was to determine whether micronized isotretinoin and standard isotretinoin are clinically equivalent. Methods: In this multicenter, double-blind, double-dummy study, 600 patients with severe recalcitrant nodular acne were treated with either 0.4 mg/kg of micronized isotretinoin once daily without food (n = 300) or 1.0 mg/kg per day of standard isotretinoin in two divided doses with food (n = 300). Lesion counts were monitored over 20 weeks. Results: Both treatment groups in this well-controlled clinical trial experienced an equivalent reduction in the number of total nodules (facial plus truncal). In addition, an equivalent proportion of patients achieved 90% clearance of the total number of nodules. Both formulations had similar results for other efficacy variables. Conclusion: Once-daily use of the micronized and more bioavailable formulation of isotretinoin under fasted conditions is clinically equivalent to the standard twice-daily formulation under fed conditions in the treatment of severe recalcitrant nodular acne. (J Am Acad Dermatol 2001;45:187-95.) |
| Databáze: | OpenAIRE |
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