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Sponsor: Premier Specialists, Australia
Conditions: Acne Cystic
Interventions: isotretinoin (Roaccutane), isotretinoin (Roaccutane)
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.
Sex: ALL
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Male or Female subjects, of any age and any race * Clinical diagnosis of nodulo-cystic acne as well as patients who have been unresponsive to standard acne vulgaris treatments Exclusion Criteria: * Pregnant or lactating female patients * Female patients with polycystic ovarian syndrome, insulin resistance syndrome, previous use of Roaccutane, patients with congenital adrenal hyperplasia, patients with any internal malignancy (excluding skin cancer) * Females of reproductive potential who refuse to take the oral contraceptive pill to take Roaccutane; patients who in the investigator's opinion would be unlikely to be compliant