Prospective trial demonstrates higher remission and reduced relapse with 1 mg/kg/day isotretinoin in high-risk acne, indicating superior long-term control.
Key Points
To develop a predictive model for acne recurrence and evaluate the efficacy and safety of systemic isotretinoin at 0.5 mg/kg/day versus 1 mg/kg/day in high-risk patients.
Logistic regression was applied to clinical, anamnestic, laboratory, and instrumental data from 511 patients to generate a recurrence prediction model.
A prospective cohort of 72 patients with moderate-to-severe acne at high recurrence risk was divided into two equal groups receiving either 1 mg/kg/day or 0.5 mg/kg/day of isotretinoin to a total cumulative dose of 120 mg/kg.
The recurrence prediction model achieved an AUC ROC of 0.910 (sensitivity 90.4%, specificity 92.5%), with key predictors including nodules (OR = 2.34), TNF-α GA genotype (OR = 1.92), disease duration >5 years (OR = 1.78), and TLR2 AA genotype (OR = 1.65).
Clinical remission was achieved in 100% of the 1 mg/kg/day group versus 88.9% of the 0.5 mg/kg/day group (p = 0.049), while the relapse rate was significantly lower at 5.6% versus 22.2% (p = 0.046).
Dose-dependent adverse events (facial erythema, mucosal dryness, and elevated transaminases) were significantly more frequent with 1 mg/kg/day (p < 0.05), but were reversible and caused no treatment discontinuations.