Effects and side effects of 2%‐progesterone cream on the skin of peri‐ and postmenopausal women: Results from a double blind, vehicle‐controlled, randomized study

Abstract

Background: Since many years topical progesterone has been prescribed by gynecologists as an anti‐aging and skin firming treatment, without any clinical scientific evidence of its effects, tolerability and its safety when topically applied to skin. Objective: The objective of this study was to evaluate the influence of 2%‐progesterone cream on the functions and texture of the skin in the peri‐ and postmenopause. Methods: A double blind, randomized, vehicle controlled study was conducted in 40 subjects. Clinical monitoring, subjective self assessment, objective measurement methods of skin elasticity, epidermal hydration and skin surface lipids and the determination of blood hormone levels (LH, FSH, estrogen, and progesterone) were used to determine effects and side effects of this treatment at four visits during 24 weeks. Results: The study demonstrated consistent superiority of 2%‐progesterone cream over vehicle in counteracting different signs of aging in the skin of peri‐ and postmenopausal women. Clinical monitoring observed higher reductions in wrinkle counts (−29,10% vs. 16,50%) and wrinkle depth (−9,72 vs. –7,35%) around the right eye, higher decrease in nasolabial wrinkle depth (−9,72% vs. –6,62%) and a significantly higher (p = 0,031) improvement of skin firmness (23,61% vs.13,24%) in the treatment group. 2%‐progesterone cream also yielded significant improvements (p < 0,05) in the objective measurement of different parameters of skin viscoelasticity and elasticity compared to the vehicle group. Epidermal hydration and skin surface lipids did not change significantly in both groups during the study. Progesterone was well absorbed in the systemic circulation, mean blood levels rose minimally, but statistically significant (p = 0,001) by 0,53 ng/nl. No serious side effects of the treatment were observed. Conclusions: The results of this study demonstrate that topical 2%‐progesterone acts primarily in a skin firming and elasticity improving manner on hormone deficient skin of the peri‐ and postmenopause. These effects in combination with good tolerability make progesterone a possible treatment agent in slowing down the aging process of the female skin after onset of menopause.