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


CONCLUSIONS
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.
Strauss
J S
JS
Department of Dermatology, University of Iowa Health Care, Iowa City, IA 52242-1090, USA.
Leyden
J J
JJ
Lucky
A W
AW
Lookingbill
D P
DP
Drake
L A
LA
Hanifin
J M
JM
Lowe
N J
NJ
Jones
T M
TM
Stewart
D M
DM
Jarratt
M T
MT
Katz
I
I
Pariser
D M
DM
Pariser
R J
RJ
Tschen
E
E
Chalker
D K
DK
Rafal
E S
ES
Savin
R P
RP
Roth
H L
HL
Chang
L K
LK
Baginski
D J
DJ
Kempers
S
S
McLane
J
J
Eberhardt
D
D
Leach
E E
EE
Bryce
G
G
Hong
J
J
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002648:Child; D004304:Dosage Forms; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015474:Isotretinoin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D013607:Tablets
D004304:Dosage Forms; D013607:Tablets; D015474:Isotretinoin