Clinical trial NCT00248989: Effect of DHEA on Skin Aging in Postmenopausal Women
Official title: Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Aging
Quality of Life
Keywords: Skin aging
Menopausal symptoms
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
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.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Clinique des Traitements Hormonaux- CHUL Research Center
state: Quebec
Study officials:
affiliation: CHUL Research Center
name: Leonello Cusan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUL Research Center
name: Fernand Labrie, MD, PhD
role: STUDY_DIRECTOR
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