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

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

Research output: Contribution to journalArticle

40 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)187-195
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume45
Issue number2
DOIs
StatePublished - 2001

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Isotretinoin
Acne Vulgaris
Food
Controlled Clinical Trials
Double-Blind Method

ASJC Scopus subject areas

  • Dermatology

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

In: Journal of the American Academy of Dermatology, Vol. 45, No. 2, 2001, p. 187-195.

Research output: Contribution to journalArticle

Strauss, JS, Leyden, JJ, Lucky, AW, Lookingbill, DP, Drake, LA, Hanifin, J, Lowe, NJ, Jones, TM, Stewart, DM, Jarratt, MT, Katz, I, Pariser, DM, Pariser, RJ, Tschen, E, Chalker, DK, Rafal, ES, Savin, RP, Roth, HL, Chang, LK, Baginski, DJ, Kempers, S, McLane, J, Eberhardt, D, Leach, EE, Bryce, G & Hong, J 2001, 'A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne', Journal of the American Academy of Dermatology, vol. 45, no. 2, pp. 187-195. https://doi.org/10.1067/mjd.2001.115965
Strauss, John S. ; Leyden, James J. ; Lucky, Anne W. ; Lookingbill, Donald P. ; Drake, Lynn A. ; Hanifin, Jon ; Lowe, Nicholas J. ; Jones, Terry M. ; Stewart, Daniel M. ; Jarratt, Michael T. ; Katz, Irving ; Pariser, David M. ; Pariser, Robert J. ; Tschen, Eduardo ; Chalker, Dan K. ; Rafal, Elyse S. ; Savin, Ronald P. ; Roth, Harry L. ; Chang, Lawrence K. ; Baginski, David J. ; Kempers, Steven ; McLane, John ; Eberhardt, Douglas ; Leach, Eileen E. ; Bryce, Graeme ; Hong, Joseph. / A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne. In: Journal of the American Academy of Dermatology. 2001 ; Vol. 45, No. 2. pp. 187-195.
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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.",
author = "Strauss, {John S.} and Leyden, {James J.} and Lucky, {Anne W.} and Lookingbill, {Donald P.} and Drake, {Lynn A.} and Jon Hanifin and Lowe, {Nicholas J.} and Jones, {Terry M.} and Stewart, {Daniel M.} and Jarratt, {Michael T.} and Irving Katz and Pariser, {David M.} and Pariser, {Robert J.} and Eduardo Tschen and Chalker, {Dan K.} and Rafal, {Elyse S.} and Savin, {Ronald P.} and Roth, {Harry L.} and Chang, {Lawrence K.} and Baginski, {David J.} and Steven Kempers and John McLane and Douglas Eberhardt and Leach, {Eileen E.} and Graeme Bryce and Joseph Hong",
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T1 - A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne

AU - Strauss, John S.

AU - Leyden, James J.

AU - Lucky, Anne W.

AU - Lookingbill, Donald P.

AU - Drake, Lynn A.

AU - Hanifin, Jon

AU - Lowe, Nicholas J.

AU - Jones, Terry M.

AU - Stewart, Daniel M.

AU - Jarratt, Michael T.

AU - Katz, Irving

AU - Pariser, David M.

AU - Pariser, Robert J.

AU - Tschen, Eduardo

AU - Chalker, Dan K.

AU - Rafal, Elyse S.

AU - Savin, Ronald P.

AU - Roth, Harry L.

AU - Chang, Lawrence K.

AU - Baginski, David J.

AU - Kempers, Steven

AU - McLane, John

AU - Eberhardt, Douglas

AU - Leach, Eileen E.

AU - Bryce, Graeme

AU - Hong, Joseph

PY - 2001

Y1 - 2001

N2 - 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.

AB - 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.

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