A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne - 02/09/11

Doi : 10.1067/mjd.2001.115965

John S. Strauss, MD^a, James J. Leyden, MD^b, Anne W. Lucky, MD^c, Donald P. Lookingbill, MD^d, Lynn A. Drake, MD^e, Jon M. Hanifin, MD^f, Nicholas J. Lowe, MD^g, Terry M. Jones, MD^h, Daniel M. Stewart, DOⁱ, Michael T. Jarratt, MD^j, Irving Katz, MD^k, David M. Pariser, MD^l, Robert J. Pariser, MD^l, Eduardo Tschen, MD^m, Dan K. Chalker, MDⁿ, Elyse S. Rafal, MD^o, Ronald P. Savin, MD^p, Harry L. Roth, MD^q, Lawrence K. Chang, MD^a, David J. Baginski, MD^a, Steven Kempers, MD^k, John McLane, PhD^r, Douglas Eberhardt, MS, MBA^r, Eileen E. Leach, MPH, RN^r, Graeme Bryce, PhD^r, Joseph Hong, MD^r
Iowa City, Iowa; Philadelphia, Pennsylvania; Cincinnati, Ohio; Jacksonville, Florida; Oklahoma City, Oklahoma; Portland, Oregon; Santa Monica and Daly City, California; Bryan and Austin, Texas; Clinton Township, Michigan; Fridley, Minnesota; Norfolk, Virginia; Albuquerque, New Mexico; Augusta, Georgia; Stony Brook, New York; New Haven, Connecticut; and Nutley, New Jersey
From the Department of Dermatology, University of Iowa Health Care, Iowa City^a; Dermatology Department, Hospital of the University of Pennsylvania, Philadelphia^b; Dermatology Research Associates, Cincinnati^c; Mayo Clinic Jacksonville^d; Department of Dermatology, University of Oklahoma Health Sciences Center^e; Oregon Health Sciences University, Portland^f; Clinical Research Specialists, Santa Monica^g; J&S Studies, Bryan^h; Midwest Cutaneous Research, Clinton Townshipⁱ; DermResearch, Austin^j; Minnesota Clinical Study Center, Fridley^k; Division of Dermatology, Eastern Virginia Medical School, Norfolk^l; Academic Dermatology Associates, Albuquerque^m; D. K. Clinical Research, Augustaⁿ; DermResearch Center of New York, Stony Brook^o; Savin Dermatology Center, New Haven^p; Harry L. Roth Professional Corporation, Daly City^q; Roche Laboratories, Inc, Nutley.^r

Abstract

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.)

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Baseline lesion counts

Change in lesion counts

Global evaluation

Discussion

	Supported by a grant from Roche LaYboratories Inc. Dr Strauss is a consultant for Roche Laboratories, Inc. Drs McLane, Bryce, and Hong, Mr Eberhardt, and Ms Leach are all employed by Roche Laboratories, Inc. None of the authors has any stock or other equity interest in Roche Laboratories, Inc.
	Reprint requests: John S. Strauss, MD, Department of Dermatology, University of Iowa Health Care, 200 Hawkins Dr, BT2045-1, Iowa City, IA 52242-1090.
	J Am Acad Dermatol 2001;45:187-95.

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Vol 45 - N° 2

P. 187-195 - août 2001 Retour au numéro

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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 M. 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. Baginski, Steven Kempers, John McLane, Douglas Eberhardt, Eileen E. Leach, Graeme Bryce, Joseph Hong

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A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne - 02/09/11

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