Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-11-01
Study Completion Date
2008-11-13
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.
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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.
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.
Conditions
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Skin Aging
Quality of Life
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Placebo
Group Type
EXPERIMENTAL
Placebos
Intervention Type
DRUG
3.0 ml of placebo cream applied on the skin twice daily.
DHEA
Group Type
EXPERIMENTAL
Dehydroepiandrosterone
Intervention Type
DRUG
3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
Interventions
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Dehydroepiandrosterone
3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
Intervention Type
DRUG
Placebos
3.0 ml of placebo cream applied on the skin twice daily.
Intervention Type
DRUG
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.
* 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.
* 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.
Minimum Eligible Age
60 Years
Maximum Eligible Age
65 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Leonello Cusan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHUL Research Center
Fernand Labrie, MD, PhD
Role: STUDY_DIRECTOR
CHUL Research Center
Locations
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Clinique des Traitements Hormonaux- CHUL Research Center
Sainte-Foy, Quebec, Canada
Site Status
Countries
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Canada
References
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Labrie F, Cusan L, Gomez JL, Martel C, Berube R, Belanger P, Chaussade V, Deloche C, Leclaire J. Changes in serum DHEA and eleven of its metabolites during 12-month percutaneous administration of DHEA. J Steroid Biochem Mol Biol. 2008 May;110(1-2):1-9. doi: 10.1016/j.jsbmb.2008.02.003. Epub 2008 Feb 14.
Reference Type
RESULT
Other Identifiers
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ERC-204
Identifier Type: -
Identifier Source: org_study_id
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