Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment
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|ClinicalTrials.gov Identifier: NCT01553773|
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Atrophy||Drug: isoflavone Drug: Estradiol||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Hyaluronic Acid Concentration in Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment: Double-blind and Randomized Clinical Trial of Efficacy|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
a gel with isoflavones (genistein 4%)
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.
Other Name: Group G
gel with 17-β estradiol 0.01%
a gel with 17-β estradiol 0.01%. Once per day. The lenght of treatment was 24 weeks.
Other Name: Group E
- Analysis of hyaluronic acid concentration in postmenopausal facial skin [ Time Frame: up to 6 months ]A number two small punch biopsy of facial skin from the preauricular area was performed before and after the 24-week gel treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553773
|Department of Gynecology - UNIFESP|
|Sao Paulo, Brazil, 04021003|
|Principal Investigator:||Marisa T Patriarca, MD, PhD||Federal University of São Paulo|