title: Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne.
abstract: Acne is a multifactorial chronic dermatosis that can be effectively treated with adjuvant medications. The objective of our study was to compare the tolerability and efficacy of 2 adjuvant therapies combining clindamycin phosphate 1.2%-benzoyl peroxide 5% (CLNP-BPO5) or clindamycin phosphate 1.2%-benzoyl peroxide 2.5% (CLNP-BPO2.5) fixed-dose gels with tazarotene (TZ) cream 0.1% (CLNP-BPO5/TZ vs CLNP-BPO2.5/TZ) when applied topically once daily for 12 weeks in participants with moderate to severe facial acne. Forty participants were randomized to receive CLNP-BPO5/TZ or CLNP-BPO2.5/TZ in a parallel-group study and were evaluated at baseline as well as weeks 1, 2, 4, 8, and 12 (or at early termination). In both groups, tolerability assessments increased by week 1 but gradually returned toward baseline levels by week 12. At week 4, the mean change in burning/stinging was significantly higher in the CLNP-BPO5/TZ group compared with the CLNP-BPO2.5/TZ group (P<.05). No other significant differences were observed for the tolerability, efficacy, quality of life (QOL), or participant preference assessments. Our study shows that CLNP-BPO5 or CLNP-BPO2.5 fixed-dose gels in combination with TZ cream 0.1% are generally well-tolerated and effective treatments of moderate to severe facial acne when applied once daily for up to 12 weeks.
authors.affiliation: Center for Dermatology Clinical Research Inc, 2557 Mowry Ave, Ste 25, Fremont, CA 94538, USA. sdhaw@yahoo.com
authors.forename: Sunil S
authors.initials: SS
authors.lastname: Dhawan
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gwazdauskas
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004338:Drug Combinations; D005145:Face; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D009539:Nicotinic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D009824:Ointments; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D012176:Retinoids
chemical_list: D001585:Benzoyl Peroxide; D002981:Clindamycin; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D009539:Nicotinic Acids; D009824:Ointments; C466951:clindamycin phosphate benzoyl peroxide combination; C086827:tazarotene; D012176:Retinoids