This randomized, single-blind, controlled trial was initiated in 2001 to compare two cumulative isotretinoin doses (120 mg/kg vs 150 mg/kg) in patients with moderate-to-severe nodulo-cystic acne. Participants were assigned to receive a cumulative dose of either 120 mg/kg or 150 mg/kg, administered according to body weight and clinical response. The primary objectives were to evaluate changes in total acne lesion counts and global acne severity grade from baseline through mid-treatment and end of treatment. Secondary objectives included assessing acne recurrence within 12 months after treatment completion and evaluating changes in acne scarring on the face, chest, and back over follow-up. A small post-hoc extension cohort included patients who had not achieved satisfactory improvement after reaching their assigned cumulative dose and continued isotretinoin beyond standard targets. These patients were analysed descriptively.
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Change in Total Acne Lesion Count During Isotretinoin Treatment
Timeframe: Baseline, Week 16, and end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached)
Change in Acne Severity Grade During Isotretinoin Treatment
Timeframe: Baseline, Week 16, and end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached)