title: Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Dermatology, University of Iowa Health Care, Iowa City, IA 52242-2090, USA.
authors.forename: J S
authors.initials: JS
authors.lastname: Strauss
authors.forename: J J
authors.initials: JJ
authors.lastname: Leyden
authors.forename: A W
authors.initials: AW
authors.lastname: Lucky
authors.forename: D P
authors.initials: DP
authors.lastname: Lookingbill
authors.forename: L A
authors.initials: LA
authors.lastname: Drake
authors.forename: J M
authors.initials: JM
authors.lastname: Hanifin
authors.forename: N J
authors.initials: NJ
authors.lastname: Lowe
authors.forename: T M
authors.initials: TM
authors.lastname: Jones
authors.forename: D M
authors.initials: DM
authors.lastname: Stewart
authors.forename: M T
authors.initials: MT
authors.lastname: Jarratt
authors.forename: I
authors.initials: I
authors.lastname: Katz
authors.forename: D M
authors.initials: DM
authors.lastname: Pariser
authors.forename: R J
authors.initials: RJ
authors.lastname: Pariser
authors.forename: E
authors.initials: E
authors.lastname: Tschen
authors.forename: D K
authors.initials: DK
authors.lastname: Chalker
authors.forename: E S
authors.initials: ES
authors.lastname: Rafal
authors.forename: R P
authors.initials: RP
authors.lastname: Savin
authors.forename: H L
authors.initials: HL
authors.lastname: Roth
authors.forename: L K
authors.initials: LK
authors.lastname: Chang
authors.forename: D J
authors.initials: DJ
authors.lastname: Baginski
authors.forename: S
authors.initials: S
authors.lastname: Kempers
authors.forename: J
authors.initials: J
authors.lastname: McLane
authors.forename: D
authors.initials: D
authors.lastname: Eberhardt
authors.forename: E E
authors.initials: EE
authors.lastname: Leach
authors.forename: G
authors.initials: G
authors.lastname: Bryce
authors.forename: J
authors.initials: J
authors.lastname: Hong
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000339:Affect / Q000187:drug effects; D001682:Biological Availability; D003863:Depression / Q000139:chemically induced; D004304:Dosage Forms; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006261:Headache / Q000139:chemically induced; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D008055:Lipids / Q000097:blood; D008111:Liver Function Tests; D009092:Mucous Membrane / Q000187:drug effects; D012867:Skin / Q000187:drug effects; D013607:Tablets; D014985:Xerophthalmia / Q000139:chemically induced
chemical_list: D004304:Dosage Forms; D008055:Lipids; D013607:Tablets; D015474:Isotretinoin