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Effect of DHEA on Skin Aging in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:
NCT00248989
First received: November 2, 2005
Last updated: April 6, 2017
Last verified: April 2017
  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 Drug: Placebos Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.

Resource links provided by NLM:


Further study details as provided by CHU de Quebec-Universite Laval:

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.

Enrollment: 150
Actual Study Start Date: November 1, 2004
Study Completion Date: November 13, 2008
Primary Completion Date: November 24, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo Drug: Placebos
3.0 ml of placebo cream applied on the skin twice daily.
Experimental: DHEA Drug: Dehydroepiandrosterone
3.0 ml of 0.3% DHEA cream applied on the skin twice daily.

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   (Adult)
Sexes 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
CHU de Quebec-Universite Laval
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.

Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT00248989     History of Changes
Other Study ID Numbers: ERC-204
Study First Received: November 2, 2005
Last Updated: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Quebec-Universite Laval:
Skin aging
Menopausal symptoms

Additional relevant MeSH terms:
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017