Quality of Life Clinical Trial
Official title:
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.
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