Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin

John S. Strauss, James J. Leyden, Anne W. Lucky, Donald P. Lookingbill, Lynn A. Drake, Jon Hanifin, Nicholas J. Lowe, Terry M. Jones, Daniel M. Stewart, Michael T. Jarratt, Irving Katz, David M. Pariser, Robert J. Pariser, Eduardo Tschen, Dan K. Chalker, Elyse S. Rafal, Ronald P. Savin, Harry L. Roth, Lawrence K. Chang, David J. BaginskiSteven Kempers, John McLane, Douglas Eberhardt, Eileen E. Leach, Graeme Bryce, Joseph Hong

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44 Scopus citations

Abstract

Background: Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formula of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously. Objective: The objective of this article is to report the incidence and intensity, of adverse events found in a comparative double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane). Methods: Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy. Results: The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin. Conclusion: Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.

Original languageEnglish (US)
Pages (from-to)196-207
Number of pages12
JournalJournal of the American Academy of Dermatology
Volume45
Issue number2
DOIs
Publication statusPublished - 2001

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ASJC Scopus subject areas

  • Dermatology

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