title: Evaluation of the efficacy, tolerability, and safety of an over-the-counter acne regimen containing benzoyl peroxide and salicylic acid in subjects with acne.
abstract: Benzoyl peroxide (BPO) is a widely used over-the-counter (OTC) topical acne treatment often used in combination with salicylic acid (SA) to achieve better comedone control than that achieved with BPO alone. MaxClarity™ is an OTC acne treatment system comprising BPO and SA in an aqueous foam delivery vehicle, VersaFoam AF™. This paper describes 2 open-label, single-arm studies conducted to assess the efficacy, safety, tolerability, and patient preference of MaxClarity in the treatment of mild, moderate, and severe acne. Subjects applied MaxClarity twice daily for 8 weeks in study 402 and for 12 weeks in study 405. Reductions in all lesion types were seen throughout both studies. At week 8 (study 402), there was a mean reduction from baseline of -56.9 ± 32.7% in total lesions in subjects with mild, moderate, or severe acne. At week 12 (study 405), there was a reduction from baseline of -61.6 ± 22.0% in total lesions in subjects with moderate or severe acne. Overall, both studies demonstrated that MaxClarity is a generally well tolerated and effective treatment for mild, moderate, and severe acne.
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Leon H
authors.initials: LH
authors.lastname: Kircik
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gwazdauskas
authors.forename: Victoria
authors.initials: V
authors.lastname: Butners
authors.forename: Joseph
authors.initials: J
authors.lastname: Eastern
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Green
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D020156:Salicylic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D004366:Nonprescription Drugs; D020156:Salicylic Acid; D001585:Benzoyl Peroxide