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 efficac y and tolerability of isotretinoin 0.1% cream in the treatment of acti nic keratoses were evaluated in a randomized, double-blind, placebo-co ntrolled, parallel-group study. Methods: One hundred patients were ran domly 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 reco rded the number of lesions in each treatment area. The 93 patients who had at least one postbaseline assessment were included for efficacy a nalysis. 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 iso tretinoin (3.9 +/- 0.6, i.e., 66% of patients with a reduction >30%) t han with placebo (1.7 +/- 0.5, i.e., 45% of patients with a reduction >30%); this difference was statistically significant (p = 0.001). No s ignificant drug effect was seen for lesions on the scalp or upper extr emities. Mild to moderate local reactions with isotretinoin abated wit h reduced treatment frequency. Conclusion: Our results suggest that is otretinoin 0.1% cream cannot compete with more rapid treatments of act inic keratoses. However, its effect on facial lesions may be beneficia l during long-term treatment of associated sun-damaged skin.