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Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.
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.
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.
Age
60 - 65 years
Sex
FEMALE
Healthy Volunteers
Yes
Clinique des Traitements Hormonaux- CHUL Research Center
Sainte-Foy, Quebec, Canada
Start Date
November 1, 2004
Primary Completion Date
November 24, 2005
Completion Date
November 13, 2008
Last Updated
April 7, 2017
150
ACTUAL participants
Dehydroepiandrosterone
DRUG
Placebos
DRUG
Lead Sponsor
CHU de Quebec-Universite Laval
NCT07444697
NCT06819592
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