A Promising New Treatment for Solar Lengtigines
April 2003 | Volume 2 | Issue 2 | Original Article | 147 | Copyright © 2003
S.I. Colby, BA; E.H. Schwartzel, PhD; F.J. Huber, BS; A. Highton, MD; D.J. Altman, MD, PHD; W.W. Epinette, MD and A. Highton, MD and E. Lyons, BS
The purpose of this open-label study was to determine the adverse event rate of topical 4HA/tretinoin when
used twice daily for up to 24 weeks with concomitant sunscreen in the treatment of solar lentigines and related
hyperpigmented lesions. There were two treatment areas: bilateral dorsal forearms, including the back of the
hands; and the face, including the forehead and cheek areas. Each treatment area had a target lesion at least
5mm in diameter and was moderately darker than the surrounding skin. A nine-point bipolar scale was used for
evaluation of Target Lesion Pigmentation (0 = extremely lighter than pigment of the surrounding skin, 4 =
equal with pigment of surrounding skin, 8 = extremely darker than pigment of surrounding skin). The other
solar lentigines present in the treatment areas also had to have an overall pigmentation grade of at least Grade
6. Twice daily applications to individual lesions in each treatment area were made for up to 24 weeks followed
by a 4-week follow-up phase. Sunscreen applications (sunscreen with sun protection factor (SPF) 25 or greater)
were made every morning and reapplied after six hours if additional sun exposure was expected. Clinical evaluations
were performed at weeks 0, 4, 8, 16, 24 and 28. The clinical signs of Target Lesion Pigmentation and
Overall Lesion Pigmentation were evaluated at each visit.
A total of 96 subjects were enrolled at four study centers; 77 (80%) subjects completed the study. Treatment-related adverse events (AEs) for 4HA/tretinoin included erythema, burning/stinging/tingling, desquamation, pruritus, skin irritation, halo hypopigmentation and hypopigmentation. Five (5%) subjects discontinued from the study due to adverse events considered to be related to study medication. When used with sunscreen of SPF 25 or greater, 4HA/tretinoin was safe and well tolerated and did not produce any unexpected or unusual adverse events.
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