Comparative efficacy and safety of two 0.025% tretinoin gels: results from a multicenter double-blind, parallel study.
BACKGROUND
The addition of polyolprepolymer-2 in tretinoin formulations may reduce tretinoin-induced cutaneous irritation.


OBJECTIVE
This study compared the efficacy and safety of a new 0.025% tretinoin gel containing polyolprepolymer-2, its vehicle, and a commercially-available 0.025% tretinoin gel in patients with mild to moderate acne vulgaris.


METHODS
In this 12-week multicenter, double-blind, parallel group study, efficacy was evaluated by objective lesion counts and the investigators' global evaluations. Subjective assessment of cutaneous irritation by the investigators and patients evaluated safety.


RESULTS
The efficacy of the two active treatments in this 215 patient study was comparable, and both treatments were statistically significantly more effective than vehicle. When compared with the commercially-available tretinoin gel, the formulation containing polyolprepolymer-2 demonstrated statistically significantly less peeling at days 28, 56, and 84, statistically significantly less dryness by day 84, and statistically significantly less itching at day 14. Irritation scores for the formulation containing polyolprepolymer-2 were numerically lower but not statistically different from those of the commercially-available gel for erythema and burning. The number of cutaneous and noncutaneous adverse events were similar for both active medications.


CONCLUSIONS
The two 0.025% gels studied demonstrated comparable efficacy. However, the gel formulation containing polyolprepolymer-2 caused significantly less peeling and drying than the commercially-available formulation by day 84 of the study.
Lucky
A W
AW
Dermatology Research Associates, Cincinnati, Ohio 45230, USA.
Cullen
S I
SI
Jarratt
M T
MT
Quigley
J W
JW
D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005782:Gels; 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
D005782:Gels; D007641:Keratolytic Agents; D009824:Ointments; D011126:Polypropylenes; D011140:Polyurethanes; C109905:polyolprepolymer-2; D014212:Tretinoin