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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00248989
Other study ID # ERC-204
Secondary ID
Status Completed
Phase Phase 3
First received November 2, 2005
Last updated April 6, 2017
Start date November 1, 2004
Est. completion date November 13, 2008

Study information

Verified date April 2017
Source Centre Hospitalier Universitaire de Québec, CHU de Québec
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 13, 2008
Est. primary completion date November 24, 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dehydroepiandrosterone
3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
Placebos
3.0 ml of placebo cream applied on the skin twice daily.

Locations

Country Name City State
Canada Clinique des Traitements Hormonaux- CHUL Research Center Sainte-Foy Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

References & Publications (60)

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* Note: There are 60 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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