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. ClinicalTrials.gov Registration: NCT02457520.