Abstract:
BACKGROUND:Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation 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.
journal_name
J Am Acad Dermatoljournal_title
Journal of the American Academy of Dermatologyauthors
Strauss JS,Leyden JJ,Lucky AW,Lookingbill DP,Drake LA,Hanifin JM,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,Mdoi
10.1067/mjd.2001.115966subject
Has Abstractpub_date
2001-08-01 00:00:00pages
196-207issue
2eissn
0190-9622issn
1097-6787pii
S0190-9622(01)78738-5journal_volume
45pub_type
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