Double-blind, placebo-controlled study of the efficacy and safety of isotretinoin cream (0.05% w/w and 0.10% w/w) with sunscreens in the treatment of mild to moderate acne vulgaris

AIM: To compare the efficacy and safety of isotretinoin cream (0.05%w/w and 0.10% w/w) formulated with standard sunscreens against placebo for the treatment of mild to mod-erate acne vulgaris in a double-blind, parallel group study. METHODS: Patients (n = 127) with a history (mean duration 3.76 years) of acne vulgaris of the face and with 15-100 inflammatory lesions and/or 15-100 non-inflammatory lesions, but not more than three nodulocystic lesions, were included. At weeks 4, 8 and 12, the investigator assessed efficacy (total number and severity of inflammatory and noninflammatory lesions), while the overall change of facial acne from baseline and skin tolerance were assessed by the investigator and patient. The investigator recorded an overall global rating of skin tolerance at week 12. Adverse events were recorded throughout. RESULTS: For all efficacy assessments, isotretinoin cream (0.05%w/w and 0.10% w/w) containing sunscreens produced statistically significant within-group improvements in the patients' acne which were statistically significant compared to placebo. The new formulation was well tolerated with overall tolerance rated as 'good' or 'excellent' for most patients. Few adverse events were reported, with none being serious. Only three skin-related events (two patients) were reported (all in the isotretinoin 0.10% w/w group), which resolved spontaneously without interruption of treatment or sequelae. CONCLUSION: Isotretinoin cream significantly improved mild to moderate acne vulgaris. There were no statistically significant differences between the two strengths but both formulations were statistically superior to the placebo control.