Double-blind, vehicle-controlled, multicenter comparison of two 0.025% tretinoin creams in patients with acne vulgaris.
BACKGROUND
Preclinical study and human patch tests indicate polyolprepolymer-2 may reduce cutaneous tretinoin-induced irritation.


OBJECTIVE
This study compared the clinical efficacy and safety of a 0.025% tretinoin cream containing polyolprepolymer-2 and its vehicle to a commercially-available 0.025% tretinoin cream.


METHODS
In this 12-week multicenter, double-blind, parallel group study in patients with mild to moderate acne, objective lesion counts and the investigators' global evaluations evaluated efficacy. Subjective evaluations of skin irritation were used to study safety.


RESULTS
A total of 271 patients were enrolled. The active treatments demonstrated comparable efficacy that was statistically significantly greater than that of the vehicle. Safety evaluations of cutaneous and noncutaneous adverse events also indicated comparable results of the active treatments.


CONCLUSIONS
The commercially-available 0.025% tretinoin cream and the 0.025% tretinoin cream containing polyolprepolymer-2 demonstrated comparable efficacy and safety.
Lucky
A W
AW
Dermatology Research Associates, Cincinnati, Ohio 45230, USA.
Cullen
S I
SI
Funicella
T
T
Jarratt
M T
MT
Jones
T
T
Reddick
M E
ME
D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007641:Keratolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D008297:Male; D009824:Ointments; D011126:Polypropylenes / Q000008:administration & dosage; D011140:Polyurethanes / Q000008:administration & dosage; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry
D007641:Keratolytic Agents; D009824:Ointments; D011126:Polypropylenes; D011140:Polyurethanes; C109905:polyolprepolymer-2; D014212:Tretinoin