Effect of DHEA on Skin Aging in Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2006 by Centre Hospitalier Universitaire de Québec, CHU de Québec.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Centre Hospitalier Universitaire de Québec, CHU de Québec

ClinicalTrials.gov Identifier:

NCT00248989

First received: November 2, 2005

Last updated: September 6, 2006

Last verified: September 2006

History of Changes

Purpose

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	Intervention	Phase
Skin Aging Quality of Life	Drug: Dehydroepiandrosterone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.

Resource links provided by NLM:

MedlinePlus related topics: Skin Aging

Drug Information available for: Prasterone

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

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.

Estimated Enrollment:	150
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	60 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248989

Locations

Canada, Quebec
Clinique des Traitements Hormonaux- CHUL Research Center
Sainte-Foy, Quebec, Canada, G1V 4G2

Sponsors and Collaborators

Centre Hospitalier Universitaire de Québec, CHU de Québec

Investigators

Principal Investigator:	Leonello Cusan, MD, PhD	CHUL Research Center
Study Director:	Fernand Labrie, MD, PhD	CHUL Research Center

More Information

Publications:

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ClinicalTrials.gov Identifier:	NCT00248989 History of Changes
Other Study ID Numbers:	ERC-204
Study First Received:	November 2, 2005
Last Updated:	September 6, 2006
Health Authority:	Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Skin aging
Menopausal symptoms

Additional relevant MeSH terms:

Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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