Does hormone therapy improve age-related skin changes in postmenopausal women? A randomized, double-blind, double-dummy, placebo-controlled multicenter study assessing the effects of norethindrone acetate and ethinyl estradiol in the improvement of mild to moderate age-related skin changes in postmenopausal women

Background: In postmenopausal women, declining estrogen levels are associated with a variety of skin changes, many of which are reportedly improved by estrogen supplementation. Objective: a study was conducted to assess the effects of continuous combined norethindrone acetate (NA) and ethinyl estradiol (EE) in the control of mild to moderate age-related skill changes in postmenopausal women. Methods: Four hundred eighty-five subjects were enrolled in this 48-week randomized, double-blind study. Subjects were randomized to one of three arms: placebo group (165 subjects), 1 mg NA/5 mu g EE group (162 subjects), or a 1 mg NA/10 mu g EE group (158 subjects). The primary efficacy parameters of the study were investigator global assessment of coarse and fine facial wrinkling at week 48 and subjective self-assessment of changes in wrinkling from baseline at week 48. Secondary parameters included investigator global assessment of skill laxity/sagging it week 48, investigator global assessment of skill texture/dryness at week 48, patient self-assessment of laxity/sagging, texture/dryness, and wrinkle depth determined by image analysis of skin replicas of the periorbital (crow's feet) and jowl areas, and skin elasticity determined by timed deformation and recoil. Results: There were similar scores in investigator global assessment in wrinkling and sagging modules at baseline across all three treatment groups. There were slight decreases in all parameters for all treatment groups for the primary subject end point, but there were no statistically significant differences between the NA/EE groups and placebo. For subject self-assessment of overall severity of skin wrinkling, there were no significant changes at weeks 24 and 48 compared to baseline. These data were unaffected by smoking status or alcohol consumption. Limitations: The study assessed the effects of 48 weeks of low-dose estrogen upon facial skin in women who where, on average, 5 years postmenopausal. The effects of higher estrogen doses, longer treatment duration, or effects upon perimenopausal women cannot he extrapolated front this study. Conclusion: Low-dose hormone therapy for 48 weeks in postmenopausal women did not significantly alter mild to moderate age-related facial skin changes.