Effect of DHEA on Skin Aging in Postmenopausal Women
This trial is active, not recruiting.
|Conditions||skin aging, quality of life|
|Sponsor||Centre Hospitalier Universitaire de Québec, CHU de Québec|
|Start date||November 2004|
|End date||December 2005|
|Trial size||150 participants|
|Trial identifier||NCT00248989, ERC-204|
The purpose of the study is to determine the response of skin parameters related to skin aging to the local action of DHEA in postmenopausal women.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Determination of local activity of DHEA for a 12 months period in parameters such as wrinkles, sebaceous gland activity, changes in skin morphology and other physical skin parameters.
Evaluation of tolerance to local skin application of DHEA for a 12 months period and potential beneficial effects on quality of life including sexual life.
Female participants from 60 years up to 65 years old.
Inclusion Criteria: - Healthy postmenopausal women who have taken hormonal replacement therapy for at least two years but not during the last 6 months prior to the study. - Aged between 60 and 65. Exclusion Criteria: - Significant dermatologic, metabolic and endocrine disease. - Diagnosis of cancer or history of hormone-dependant cancer. - Over exposure to sun or tanning session during the previous two months. - Narcotic addiction, alcoholism or smoking.
|Official title||Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.|
|Principal investigator||Leonello Cusan, MD, PhD|
|Description||Humans, along with the others primates, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone(DHEA)and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Moreover, much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid. Therefore this study proposes to study the effect of 0.3% DHEA cream during a period of 12 months administered twice daily to postmenopausal women. During the study several biological and clinical parameters will be evaluated. In summary, these include blood steroid levels, distribution of hormonal receptors in the skin, sebaceous gland activity, skin hydration, skin wrinkles and finally skin genomic evaluation. Subjects will be evaluated at specific time intervals for the above mentioned parameters as well as tolerability and adverse reactions.|
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