Adapalene-benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients.
BACKGROUND
Combination therapy utilizing agents with complementary mechanisms of action is recommended by acne guidelines to help simultaneously target multiple pathogenic factors. A unique, topical, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has recently been developed for the once-daily treatment of acne.


OBJECTIVE
To evaluate the efficacy and safety of adapalene 0.1%-BPO 2.5% fixed-dose combination gel (adapalene-BPO) relative to adapalene 0.1% monotherapy (adapalene), BPO 2.5% monotherapy (BPO), and the gel vehicle (vehicle) in a large population for the treatment of acne vulgaris.


METHODS
In total, 1670 subjects were randomized in a double-blind controlled trial to receive adapalene-BPO, adapalene, BPO or vehicle for 12 weeks (1 : 1 : 1 : 1 randomization). Evaluations included success rate (subjects 'clear' or 'almost clear'), percentage change in lesion count from baseline, cutaneous tolerability and adverse events.


RESULTS
Adapalene-BPO was significantly more effective than corresponding monotherapies, with significant differences in percentage lesion count change observed as early as 1 week. Cutaneous tolerability profile was similar to adapalene. Adverse events were more frequent with the combination therapy (mainly due to an increase in mild-to-moderate dry skin), occurred early in the study, and were transient.


CONCLUSIONS
Adapalene-BPO provides significantly greater and synergistic efficacy and a faster onset of action with an acceptable safety profile in the treatment of acne vulgaris when compared with the corresponding vehicle and the adapalene and BPO monotherapies.
Gollnick
H P M
HP
Department of Dermatology and Venereology, Otto-von-Guericke Universität Magdeburg, 39120 Magdeburg, Germany.
Draelos
Z
Z
Glenn
M J
MJ
Rosoph
L A
LA
Kaszuba
A
A
Cornelison
R
R
Gore
B
B
Liu
Y
Y
Graeber
M
M
D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000009:adverse effects / Q000627:therapeutic use*; D001585:Benzoyl Peroxide / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D009281:Naphthalenes; D000068816:Adapalene; D001585:Benzoyl Peroxide