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.
BACKGROUND
For many years topical progesterone has been prescribed by gynaecologists as an antiageing and skin-firming treatment, without any clinical scientific evidence of its effects, tolerability and safety when applied to skin.


OBJECTIVE
To evaluate the influence of 2% progesterone cream on function and texture of the skin in peri- and postmenopausal women.


METHODS
A double-blind, randomized, vehicle-controlled study was conducted in 40 subjects. Objective methods for measuring skin elasticity, epidermal hydration and skin surface lipids, clinical monitoring and self-assessment, and determination of blood hormone levels (luteinizing hormone, follicle-stimulating hormone, oestrogen and progesterone) were used to determine effects and side-effects of this treatment at four visits over a 16-week period.


RESULTS
The study demonstrated a significant (P < or = 0.05) increase of the elastic skin properties in the treatment group, as demonstrated by objective measurements of three skin elasticity parameters, whereas in the control group no such effect was observed. This effect in the treatment group was further paralleled by the results of the clinical monitoring, where the 2% progesterone cream yielded consistent superiority over vehicle in counteracting different signs of ageing in the skin of peri- and postmenopausal women. Clinical monitoring showed a greater reduction in wrinkle counts (29.10% vs. 16.50%) and wrinkle depth (9.72% vs. 7.35%) around the right eye, a greater decrease in nasolabial wrinkle depth (9.72% vs. 6.62%) and a significantly higher (P < 0.05) increase in skin firmness (23.61% vs. 13.24%) in the treatment group. Epidermal hydration and skin surface lipids did not change significantly in either group during the study. Progesterone was well absorbed in the systemic circulation: mean blood levels rose minimally, but statistically significantly (P = 0.001), by 0.53 ng mL(-1). No serious side-effects of the treatment were observed.


CONCLUSIONS
The results of this study demonstrate that topical 2% progesterone acts primarily in increasing elasticity and firmness in the skin of peri- and postmenopausal women. These effects in combination with good tolerability make progesterone a possible treatment agent for slowing down the ageing process of female skin after onset of the menopause.
Holzer
G
G
Division of Special and Environmental Dermatology, Medical University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria. gregor.holzer@meduniwien.ac.at
Riegler
E
E
Hönigsmann
H
H
Farokhnia
S
S
Schmidt
J B
JB
Schmidt
B
B
D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004548:Elasticity; D004967:Estrogens / Q000097:blood; D005145:Face; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008593:Menopause / Q000097:blood; D008875:Middle Aged; D009333:Neck; D009824:Ointments; D011374:Progesterone / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D012647:Self-Assessment; D012867:Skin / Q000187:drug effects* / Q000503:physiopathology; D012869:Skin Absorption; D015595:Skin Aging / Q000187:drug effects*; D018709:Statistics, Nonparametric
D004967:Estrogens; D009824:Ointments; D011374:Progesterone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone