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Effect of DHEA on Skin Aging in Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248989
First Posted: November 4, 2005
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval
November 2, 2005
November 4, 2005
April 7, 2017
November 1, 2004
November 24, 2005   (Final data collection date for primary outcome measure)
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
Effect of DHEA on Skin Aging - 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Skin Aging
  • Quality of Life
  • Drug: Dehydroepiandrosterone
    3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
  • Drug: Placebos
    3.0 ml of placebo cream applied on the skin twice daily.
  • Experimental: Placebo
    Intervention: Drug: Placebos
  • Experimental: DHEA
    Intervention: Drug: Dehydroepiandrosterone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
November 13, 2008
November 24, 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
60 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00248989
ERC-204
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
CHU de Quebec-Universite Laval
CHU de Quebec-Universite Laval
Not Provided
Principal Investigator: Leonello Cusan, MD, PhD CHUL Research Center
Study Director: Fernand Labrie, MD, PhD CHUL Research Center
CHU de Quebec-Universite Laval
April 2017

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