While the efficacy and safety of topical
4-hydroxyanisole (
mequinol) 2%/
tretinoin 0.01%
therapy has been established in Caucasian populations, those with skin types I-II, little research has focused on individuals with darker skin types. The purpose of this open-label study was to evaluate the efficacy and safety of
mequinol 2%/
tretinoin 0.01%
solution in the treatment of solar
lentigines in Asian, Latin/Hispanic, and African American ethnic groups with skin types II-V. Subjects were required to have >or= 10 solar
lentigines on the dorsal forearms/hands and >or= 3 on the face. One lesion was designated the target lesion, however, all lesions were treated. Patients were treated with topical
mequinol 2%/
tretinoin 0.01% and clinically evaluated at 4, 8, 12, 16, 20, and 24 weeks as well as 4 weeks following
treatment cessation. At each visit, lesions were evaluated using Target and Overall Lesion Pigmentation Index scores ranging from 0 (lightest) to 8 (darkest), where 4 indicated equal pigment with surrounding skin. Efficacy was determined based on pigmentation index scores, and safety was assessed using laboratory monitoring and adverse event (AE) reporting. Over 80% of the 259 subjects completing this study responded to
mequinol 2%/
tretinoin 0.01%
therapy, with a majority of subjects maintaining clinical benefit at 4 weeks post-treatment. Most AEs reported were tolerable and overall
mequinol 2%/
tretinoin 0.01%
therapy had a favorable benefit-to-risk ratio. This study therefore supports the theory that topical
mequinol 2%/
tretinoin 0.01% is an effective and safe treatment of solar
lentigines in ethnic populations, and in those with dark skin types.