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A phase IIIb, multicenter, randomized, investigator-blinded, controlled, parallel group, 20-week noninferiority trial compared two treatments in 217 patients (age, 12–35 years) with severe nodulocystic acne. Eligible patients were randomized to once-daily doses of oral isotretinoin (0.5 mg/kg, escalated to 1 mg/kg after 4 weeks) or oral doxycycline hyclate 200 mg plus topical gel containing both adapalene 0.1% and benzoyl peroxide 2.5% (D+A/BPO). Makers of the A/BPO gel funded the study.
At week 2, D+A/BPO recipients had better nodule reduction than patients receiving the start-up dose of isotretinoin (40% vs. 24%; P<0.001). By week 20, 92% of isotretinoin recipients versus 76% of D+A/BPO recipients had such response (P<0.001). In both group…