NCT00248989

Effect of DHEA on Skin Aging in Postmenopausal Women

Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 60 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Skin Aging
• Quality of Life

Interventions

Type	Name	Description
DRUG	Dehydroepiandrosterone	3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
DRUG	Placebos	3.0 ml of placebo cream applied on the skin twice daily.

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-11-24
• Completion: 2008-11-13
• First posted: 2005-11-04
• Last updated: 2017-04-07

Locations

1 site across 1 country: Canada