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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Labrie F, Simard J, Luu-The V, Bélanger A, Pelletier G, Morel Y, Mebarki F, Sanchez R, Durocher F, Turgeon C, Labrie Y, Rhéaume E, Labrie C, Lachance Y. The 3b-hydroxysteroid dehydrogenase/isomerase gene family: lessons from type II 3b-HSD congenital deficiency. In: Signal Transduction in Testicular Cells. Ernst Schering Research Foundation Workshop. Hansson V, Levy FO, Taskén K (eds), Berlin, Heidelberg, New York, Springer-Verlag, Vol. Suppl. 2: pp. 185-218, 1996.
Notelovitz M, Watts N, Timmons C, Addison A, Wiita B, Downey L. Effects of estrogen plus low dose androgen vs estrogen alone on menopausal symptoms in oophorectomized/hysterectomized. North Am. Menopause Soc., Montreal 1991, 101.
Studd J W, Collins W P, Chakravarti S, Newton J R, Oram D, Parsons A. Estradiol and testosterone implants in treatment of psochosexual problems in postmenopausal women. Br. J. Obstet. Gynecol. 84: 314-315, 1987.

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 August 27, 2014