Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen.
Topical tretinoin and benzoyl peroxide (BPO) are often prescribed in combination for the treatment of acne vulgaris; however, these products have not traditionally been administered simultaneously because of the potential for tretinoin degradation by BPO as well as the instability of tretinoin in daylight. The primary objective of this randomized, investigator-blinded, 12-week, phase 4 trial was to determine non-inferiority of a once-daily morning combination regimen of 5% BPO wash + tretinoin gel microsphere (TGM) 0.04% pump versus a sequential regimen (BPO in the morning/TGM in the evening) in patients > or = 12 years old with moderate facial acne vulgaris. The primary efficacy endpoint was the change from baseline in total acne lesions; the primary safety endpoint was the change in cutaneous irritation scores. The 247 participants (mean age: 18.5 years) were randomized to either the morning/morning regimen (n = 123) or the morning/evening regimen (n = 124). The morning/morning regimen was determined to be non-inferior to the morning/evening regimen in reduction of total acne lesions. The tolerability of both regimens was comparable. The morning/morning regimen is a safe and effective treatment option for patients with moderate acne vulgaris.
Pariser
David
D
Department of Dermatology, Eastern Virginia Medical School, Virginia Clinical Research, Inc., Norfolk, VA, USA. dpariser@pariserderm.com
Bucko
Alicia
A
Fried
Richard
R
Jarratt
Michael T
MT
Kempers
Steven
S
Kircik
Leon
L
Lucky
Anne W
AW
Rafal
Elyse
E
Rendon
Marta
M
Weiss
Jonathan
J
Wilson
David C
DC
Rossi
Ana Beatris
AB
Ramaswamy
Ratna
R
Nighland
Marge
M
D000152:Acne Vulgaris / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects
D005782:Gels; D014212:Tretinoin; D001585:Benzoyl Peroxide