IRCT20170806035524N5.

Trial name or title	Comparing efficacy of combination therapy with niosomal benzoyl peroxide 1% ‐ clindamycin 1% versus niosomal clindamycin 1% in acne vulgaris: a randomized clinical trial
Methods	Study design: parallel, triple‐blind design Duration of follow‐up: 12 weeks
Participants	Inclusion criteria Male or female aged 12 to 30 years Mild to moderate acne vulgaris Exclusion criteria Pregnancy or lactation History of allergy to clindamycin or BPO Previous history of inflammatory bowel disease, colitis, polycystic ovary syndrome, or hirsutism Taking neuromuscular blocker or oral anti‐acne drug since 6 months ago Topical anti‐acne drug since 1 month ago Sites of acne: face
Interventions	Interventions in Group A Topical treatment: BPO plus clindamycin Regimen: leave‐on Concentration: BPO: 1%; clindamycin: 1% Vehicle: BPO: gel; clindamycin: lotion Dose: twice daily Duration: 12 weeks Interventions in Group B Topical treatment: clindamycin Regimen: leave‐on Concentration: 1% Vehicle: gel Dose: twice daily Duration: 12 weeks
Outcomes	Primary outcomes of review interest None Secondary outcomes of review interest Inflammatory and non‐inflammatory acne lesion count Quality of life assessed via Cardiff Acne Disability Index (CADI) questionnaire Other outcomes reported in the study Acne lesion severity measured by physician using GAGS (Global Acne Grading System) Side effects (erythema, scaling, and pruritus)
Starting date	June 2018
Contact information	Mahin Aflatoonian Kerman University of Medical Sciences maaflatoonian@gmail.com
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