Effect of DHEA on Skin Aging in Postmenopausal Women
Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Completed
CT.gov ID
NCT00248989
Collaborator
(none)
150
1
2
48.4
3.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.
Actual Study Start Date
:
Nov 1, 2004
Actual Primary Completion Date
:
Nov 24, 2005
Actual Study Completion Date
:
Nov 13, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Placebo
|
Drug: Placebos
3.0 ml of placebo cream applied on the skin twice daily.
|
| Experimental: DHEA
|
Drug: Dehydroepiandrosterone
3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
|
Outcome Measures
Primary Outcome Measures
- 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. []
Secondary Outcome Measures
- 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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique des Traitements Hormonaux- CHUL Research Center | Sainte-Foy | Quebec | Canada | G1V 4G2 |
Sponsors and Collaborators
- CHU de Quebec-Universite Laval
Investigators
- Principal Investigator: Leonello Cusan, MD, PhD, CHUL Research Center
- Study Director: Fernand Labrie, MD, PhD, CHUL Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
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- Labrie F, Bélanger A, Cusan L, Candas B. Physiological changes in dehydroepiandrosterone are not reflected by serum levels of active androgens and estrogens but of their metabolites: intracrinology. J Clin Endocrinol Metab. 1997 Aug;82(8):2403-9.
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Responsible Party:
CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:
NCT00248989
Other Study ID Numbers:
- ERC-204
First Posted:
Nov 4, 2005
Last Update Posted:
Apr 7, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CHU de Quebec-Universite Laval
Additional relevant MeSH terms: