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

November 2, 2005
September 6, 2006
November 2004
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00248989 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of DHEA on Skin Aging in Postmenopausal Women
Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Skin Aging
  • Quality of Life
Drug: Dehydroepiandrosterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2005
Not Provided

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.
Female
60 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00248989
ERC-204
Not Provided
Not Provided
Centre Hospitalier Universitaire de Québec, CHU de Québec
Not Provided
Principal Investigator: Leonello Cusan, MD, PhD CHUL Research Center
Study Director: Fernand Labrie, MD, PhD CHUL Research Center
Centre Hospitalier Universitaire de Québec, CHU de Québec
September 2006

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