Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment
Condition: Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): isoflavone; Estradiol
Intervention type(s): Drug; Drug
Intervention description(s): treatments: a gel with 17-β estradiol 0.01% (n = 15) and a gel with isoflavones (genistein 4%). The gels were applied once per day. the lenght of treatment was 24 weeks.; a gel with 17-β estradiol 0.01%. Once per day. The lenght of treatment was 24 weeks.
Other intervention name(s): Group G; Group E
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyaluroic acid; Estradiol; Isoflavone; Skin; Postmenopause