This trial is active, not recruiting.

Conditions skin aging, quality of life
Treatment dehydroepiandrosterone
Phase phase 3
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Start date November 2004
End date December 2005
Trial size 150 participants
Trial identifier NCT00248989, ERC-204


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

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.
time frame:

Secondary Outcomes

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.
time frame:

Eligibility Criteria

Female participants from 60 years up to 65 years old.

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.

Additional Information

Official title Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.
Principal investigator Leonello Cusan, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.