Effect of DHEA on Skin Aging in Postmenopausal Women
|Skin Aging Quality of Life||Drug: Dehydroepiandrosterone Drug: Placebos||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.|
- 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.
- 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.
|Actual Study Start Date:||November 1, 2004|
|Study Completion Date:||November 13, 2008|
|Primary Completion Date:||November 24, 2005 (Final data collection date for primary outcome measure)|
3.0 ml of placebo cream applied on the skin twice daily.
3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248989
|Clinique des Traitements Hormonaux- CHUL Research Center|
|Sainte-Foy, Quebec, Canada, G1V 4G2|
|Principal Investigator:||Leonello Cusan, MD, PhD||CHUL Research Center|
|Study Director:||Fernand Labrie, MD, PhD||CHUL Research Center|