Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this trial was to compare the effects of estradiol or genistein treatment on the hialuronic acid concentration on the postmenopausal facial skin. In this study, 30 postmenopausal women were evaluated through a prospective, randomized, double-blind trial. The volunteers were postmenopausal women treated in the Gynecology Department of the Federal University of São Paulo (UNIFESP). The participants were divided into two groups: group E, treated with 17 β estradiol gel 0.01% (n = 15), and group G, treated with genistein gel 4 % (isoflavones, n=15). The length of treatment was 24 consecutive weeks. Preauricular skin biopsies were performed on each patient before and after the treatment for evaluating hyaluronic acid in the tissue. The materials were processed through immunohistochemical and biochemical methods.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo
• Collaborator: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Genistein; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• two to five years postmenopause;

• FSH > 40 mU/ml;

• estrogen levels < 20 pg/ml;

• body mass index (BMI) < 30 kg/m2

Exclusion Criteria:

• treatment with estrogens or soybeans for the previous 12 months;

• tobacco user;

• women who had a contraindication for hormone therapy, who had been using retinoids or herbal substances, and those who had a history of collagen diseases.

• also, strict vegetarianism, high fiber- or high soy-diet consumption;

• regular consumption of vitamin and mineral supplementation greater than the Recommended Dietary Allowances;

• antibiotic treatment;

• a history of chronic disorders, including endocrine or gynecological diseases or neoplasia, as well as benign breast disease; and

• regular use of medication known to interfere with the study endpoints.

• patients with cervico-vaginal cytology classified as Papanicolaou Class III or more were also excluded.

• participants with hypertension who were using two or more antihypertensive drugs were not included in this study.