Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248989
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2005-11-02
Brief Title:
Effect of DHEA on Skin Aging in Postmenopausal Women
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 dehydroepiandrosteroneDHEAand 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 03 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
Therefore this study proposes to study the effect of 03 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None