Purpose Acne vulgaris is a skin disorder primarily affecting teenagers and young adults. Acne relapse is the main drawback of oral isotretinoin (OI), which is the golden therapy for severe acne. This study aimed to assess the rate and predictive factors of acne relapse among Sudanese patients using OI. Patients and Methods A cross-sectional study was conducted in a dermatology and venereology clinic-Sudan, using a self-administered questionnaire and data collection sheet. Patients using OI for acne treatment were enrolled in the study. Chi-square test and logistic regression analysis were used to evaluate the association between variables. P-value <0.05 was considered statistically significant. Results 225 acne patients (mean age: 26.0±4.2 years, females: 88.9%) were included in this study. OI daily dose ranged from 0.25 to 1 mg/kg/day, with frequent daily doses of 40–49 mg (57.3%) over 3–6 months (81.8%). Around one-third of patients (36%) received maintenance therapy after completion of OI course. At a 2-year follow-up, approximately 36% of patients experienced acne relapse that commonly occurred within 6–18 months after the last OI therapy. Early discontinuation of OI was a positive predictor of acne relapse which was 3.99 times greater in patients who had early discontinued OI than those completing the planned OI course (OR=3.99; p =0.002). OI cumulative doses of 120–139 mg/kg and 140–159 mg/kg were negative predictors of acne relapse (OR=0.23; p =0.001 and OR=0.15; p =0.02, respectively). Most patients (94.2%) received prescription OI, and 76.4% of women were advised to use contraceptives. About 69% of patients practiced skin care. Conclusion About one-third of patients experienced acne relapse. Early discontinuation and low cumulative doses of OI are the main risk factors for acne relapse. Long-term therapy of OI, with cumulative doses of 120–159 mg/kg, would be beneficial to reduce acne relapse.
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