CLINICAL-EVALUATION OF TOPICAL ISOTRETINOIN IN THE TREATMENT OF ACTINIC KERATOSES

Background: Retinoids have been shown to improve the manifestations of skin photodamage, including actinic keratoses. Objective: The efficacy and tolerability of isotretinoin 0.1% cream in the treatment of actinic keratoses were evaluated in a randomized, double-blind, placebo-controlled, parallel-group study. Methods: One hundred patients were randomly assigned to treatment with 0.1% cream or Vehicle twice daily for 24 weeks to the face, the scalp, and the upper extremities. Patients were assessed every 4 weeks by the investigators, who counted and recorded the number of lesions in each treatment area. The 93 patients who had at least one postbaseline assessment were included for efficacy analysis. Local tolerability was evaluated at each study visit. Results: On the face, the reduction in number of actinic keratoses (mean +/- SEM) at the end of treatment was greater for patients treated with isotretinoin (3.9 +/- 0.6, i.e., 66% of patients with a reduction >30%) than with placebo (1.7 +/- 0.5, i.e., 45% of patients with a reduction >30%); this difference was statistically significant (p = 0.001). No significant drug effect was seen for lesions on the scalp or upper extremities. Mild to moderate local reactions with isotretinoin abated with reduced treatment frequency. Conclusion: Our results suggest that isotretinoin 0.1% cream cannot compete with more rapid treatments of actinic keratoses. However, its effect on facial lesions may be beneficial during long-term treatment of associated sun-damaged skin.