Effect of DHEA on Skin Aging in Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.

Conditions
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Skin Aging, Quality of Life

Intervention / Treatment
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* Drug: Dehydroepiandrosterone
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br> | Drug: Placebos<br>* 3.0 ml of placebo cream applied on the skin twice daily.<br>|
| Experimental: DHEA<br> | Drug: Dehydroepiandrosterone<br>* 3.0 ml of 0.3% DHEA cream applied on the skin twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin aging, Menopausal symptoms