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

Tracking Information

First Received Date ^ICMJE

November 2, 2005

Last Updated Date

September 6, 2006

Start Date ^ICMJE

November 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00248989 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of DHEA on Skin Aging in Postmenopausal Women

Official Title ^ICMJE

Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.

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 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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Skin Aging
Quality of Life

Intervention ^ICMJE

Drug: Dehydroepiandrosterone

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

150

Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

60 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00248989

Other Study ID Numbers ^ICMJE

ERC-204

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Québec, CHU de Québec

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Centre Hospitalier Universitaire de Québec, CHU de Québec

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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