Atrophy Clinical Trial
Official title:
Hyaluronic Acid Concentration in Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment: Double-blind and Randomized Clinical Trial of Efficacy
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.
Postmenopausal volunteers were recruited in Brazil from the Endocrinological Gynecology
Division of the Gynecology Department of Federal University of São Paulo (UNIFESP). All
women participated in this prospective, randomized, double-blind and estrogen-controlled
study and approved by the local Ethics and Research Committee (Report No 386/2004). The
evaluation of all of the subjects consisted of a detailed history, a physical exam, and a
laboratory workup. The study protocol was approved by the UNIFESP School of Medicine Human
Investigation Committee, and every participant had to provide written informed consent
before enrollment.
Intervention Independent pharmacists dispensed either isoflavone or estrogen containers
according to a computer-generated randomization list. The containers, as well as a jar for
treatments, had identical appearance and color. The researchers were responsible for seeing
the women allocated the next available number on entry into the trial, and each woman
collected her containers directly from the pharmacy department. The code was revealed to the
researchers once recruitment, data collection, and histological analyses were complete. If a
health problem occurred, an independent physician who was blinded to the patient's treatment
group examined her. If necessary, this physician prescribed laboratory exams for exclusion
of any serious systemic side-effects. A number two punch biopsy of facial skin from the
preauricular area was performed before and after the 24-week gel treatment. The women
applied the gel on their facial skin daily at night, and in the morning, they used a gel
sunscreen only. They were advised not to use any other cream. To assess possible systemic
hormonal effects, hormonal vaginal cytology samples were taken at all visits (baseline and
after 6, 12, 18, and 24 weeks of treatment) and estradiol blood samples before and after the
treatment.
Groups The participants flowed through each stage of the study. After the end of study, the
label was opened, and the treatment groups with the same number were classified. Fifteen
patients were required for each study group: group E, treated with a gel with 17-β estradiol
0.01% (n = 15), and group G, treated with a gel with isoflavones (genistein 4%) (n = 15).
Processing of the material After the collection, the biopsies were immediately fixed for 24
hours in 10% formaldehyde solution and then processed for paraffin via dehydration in
ethanol in increasing concentrations, diaphanization in xylol and impregnation by liquid
paraffin in drying oven set at a temperature of 60 °C (methodology recommended by Michalany,
1998). The paraffin blocks were submitted to cuts of 3 μm with a Minot microtome. The cuts
for immunohistochemistry were placed on slides previously treated with silane to 5 % and
brought to oven at 37 °C for 24 hours for drying. Additionally, sections were made of 20 μm
and placed in tubes of 2ml for the biochemical processing.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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