Long-term safety and efficacy of a unique fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% for the treatment of acne vulgaris.
BACKGROUND
A unique, once-daily, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BP) 2.5% has been developed for the treatment of acne vulgaris.


OBJECTIVE
To evaluate the long-term (up to 12 months) safety and efficacy of the adapalene 0.1%/BP 2.5% fixed-dose combination gel for the treatment of acne vulgaris.


METHODS
A total of 452 subjects were enrolled in this 12-month study and received adapalene/BP once daily. Evaluations included lesion count reduction, subject's assessment of acne, adverse events, and cutaneous tolerability.


RESULTS
Adverse events were mild to moderate, occurred early in the study, and decreased thereafter. Discontinuations due to adverse events were low (2.0%) and no subjects discontinued due to lack of efficacy. Early and sustained reductions in inflammatory and noninflammatory lesions were observed, with clinically significant lesion reductions as early as week 1.


CONCLUSIONS
These findings are consistent with previous clinical findings and support the use of a once-daily adapalene/BP fixed-dose combination as a safe and effective treatment in the long-term management of acne.
Pariser
David M
DM
Virginia Clinical Research, Inc and Eastern Virginia Medical School, Norfolk, VA 23507, USA.
Westmoreland
Patricia
P
Morris
Amy
A
Gold
Michael H
MH
Liu
Yin
Y
Graeber
Michael
M
D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000068816:Adapalene; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology; D008297:Male; D009281:Naphthalenes / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D012176:Retinoids / Q000737:chemistry; D012867:Skin / Q000187:drug effects / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
D003879:Dermatologic Agents; D004338:Drug Combinations; D009281:Naphthalenes; D012176:Retinoids; D000068816:Adapalene; D001585:Benzoyl Peroxide