An Open-label, Phase IV study evaluating lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: Low relapse rates observed over the 104-week post-treatment period

Objective: We sought to evaluate long-term relapse rates following lidose-isotretinoin taken without food in patients with severe recalcitrant acne. Design: In this single-arm, open-label study, 197 patients received twice-daily lidose-isotretinoin without food for up to 20 weeks. Patients with a 75-percent or higher adherence rate with the protocol-designated dosage and end-of-treatment lesion counts were predefined as the per-protocol (PP) population and evaluated in a 104-week post-treatment period (PTP) to determine the proportion of patients requiring retreatment. Setting: Participants were enrolled from 21 sites across the United States. Participants: Eligible participants were male or nonpregnant, nonlactating female, aged between 12 to 45 years, weighing 40 to 110 kg, and with no prior exposure to systemic isotretinoin or systemic retinoids. Acne was considered severe enough for treatment if the patient had five or more facial nodule lesions. Measurements: Patients were observed to determine whether they required retreatment with isotretinoin or any acne therapy during the PTP. Lesion counts and assessments of acne severity, quality of life, and adverse events were completed. Results: Of the 166 patients in the PP population, seven (4.2%; 95% confidence interval [CI]: 1.7%–8.5%) were retreated with isotretinoin, 25 (15.1%; 95% CI: 10.0%–21.4%) were treated with topical and/ or oral nonisotretinoin therapies including over-the-counter therapies or intralesional injections, and 137 (82.5%; 95% CI: 75.8%–88.0%) required no retreatment. Isotretinoin retreatment was most common in male patients aged 14 to 18 years. Conclusion: Long-term relapse rates for lidose-isotretinoin taken without food for 20 weeks were at the low end of those published for traditional isotretinoin taken with a high-fat/high calorie meal.