Community study of fixed-combination adapalene 0.1% and benzoyl peroxide 2.5% in acne.
A new fixed-dose combination formulation of adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has shown excellent efficacy and safety in registration studies; however, it can be difficult to judge the real-world performance of a product using only the results from controlled clinical trials. This 12-week, open-label, community-based study evaluated adapalene/BPO in 91 patients with mild to moderate acne (20-50 inflammatory lesions and 30-100 noninflammatory lesions) who were treated at dermatology centers throughout Argentina. The study evaluated efficacy, described the most common side effects, determined tolerability, and assessed the level of patient satisfaction with treatment. By week 12, there were statistically significant reductions in both inflammatory and noninflammatory lesions (80.6% and 69.3% from baseline, respectively; P < .001); there were also significant improvements in the Investigator's Global Assessment scores (median score, 2.9 at baseline and 1.0 at week 12; P < .001). By week 12, 67% of patients were rated clear or almost clear by investigators. Local tolerability was good overall. When cutaneous irritation was present, it typically occurred in the first 2 weeks of treatment and improved or resolved with continuing therapy. Patients were highly satisfied with the results of treatment, and 74% of patients felt that they had marked or total improvement by week 12. Patient survey also revealed that 94% rated the efficacy as good or very good and 87.5% rated tolerability as good or very good. A significant majority (81%) felt that the treatment met expectations, and 62% perceived that improvement had been rapid during adapalene/BPO therapy. These results demonstrate that adapalene/BPO has good efficacy and tolerability in routine practice, resulting in continuous reductions in lesion counts throughout the study. Adapalene/BPO therapy is also associated with high patient satisfaction, which is important for therapeutic adherence and satisfaction with the physician's care.
Troielli
Patricia A
PA
Argentina Epiduo Study Group, Buenos Aires, La Plata, Cordoba, Tucuman, and Santa Fe, Argentina. ptroielli@gmail.com.ar
Asis
Beatriz
B
Bermejo
Alcira
A
Bittar
Mario
M
Cabrera
Hugo
H
Castro
Carla
C
Chouela
Ezequiel
E
Cordero
Andrés
A
Dobrinin
Roberto
R
Escobar
Sergio
S
Fortino
Mirta
M
Galimberti
Daniel
D
Galimberti
Gaston
G
Giovo
Maria Elsa
ME
Gomez
Beatriz
B
Gras
Maria del Carmen
Mdel C
Ibarra
Mónica
M
Kizlansky
Viviana
V
Chabbert
Patricio Martinez
PM
Ramonda
Sergio
S
D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001585:Benzoyl Peroxide / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage*; D017060:Patient Satisfaction; D016896:Treatment Outcome; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D009281:Naphthalenes; D000068816:Adapalene; D001585:Benzoyl Peroxide