Aims: To determine the safety and efficacy of a cream formulation of 0.05% isotretinoin with sunscreens (SPF 15) (I+S) in the treatment of photoaged skin.
Design and subjects: A 6-month, multicentre, randomized, double-blind, parallel-group, vehicle-controlled study of 346 subjects with photoaged skin, as defined by the presence of fine lines in the periorbital region. The main outcome measure was profilometry measurements of replicas of the periorbital region, taken at 0 and 6 months. Subsidiary outcome measures were clinical scoring of wrinkles/fine lines at 0, 1, 3, 6 and 9 months and histopathology at 0 and 6 months.
Methods and results: A total of 172 subjects were randomized to 0.05% I+S and 174 subjects to vehicle. Subjects used the study medication topically, once-daily for 6 months, followed by a 3-month washout period. Profilometry measurements of the distance between the highest peak and lowest valley (Rz) and the distance between all valleys and peaks from mid-line (Ra) showed that subjects using I+S had statistically significant improvement (p<0.05) compared with the vehicle group. Additionally, at all visits, VAS clinical scoring of wrinkles/fine lines showed a statistically significant difference between the groups in favour of I+S. Tolerance assessments showed that more subjects in the I+S group experienced local side effects at the start of the study; however, reports of side effects decreased over time in both groups.
Conclusion: This study confirms that I+S improves the appearance of fine wrinkles associated with photoaged skin.