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STUDY DESIGN
Design:
randomised placebo-controlled trial.
Allocation:
{concealed}*.†
Blinding:
blinded {patients, healthcare providers, data collectors, outcome assessors, and data analysts}*.†
STUDY QUESTION
Setting:
66 centres in the USA, 1 in Canada, and 1 in Belize.
Patients:
2813 patients ⩾12 years of age (mean age 19 y, 52% women) who had moderate-to-severe acne vulgaris (grade 3–4 on 6-grade Evaluator Global Severity Score [EGSS]); presented with 17–40 inflammatory lesions (papules, pustules, and nodules), 20–100 non-inflammatory lesions (open and closed comedones), and ⩽2 nodules; and used a washout period (1 wk–6 mo) for any prior acne treatment. Women had to use contraception during the study.
Intervention:
once-daily combined clindamycin phosphate 1.2% and benzoyl peroxide 2.5% gel (CP-BPO, n = 797), CP …
Footnotes
Source of funding: Arcutis Pharmaceuticals.