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Completed

NCT Number: NCT00248989

Effect of DHEA on Skin Aging in Postmenopausal Women

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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Key information

Conditions

Skin Aging Quality of Life

Age range

60 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Clinique des Traitements Hormonaux- CHUL Research Center

Sainte-Foy, Quebec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dehydroepiandrosterone

Drug

3.0 ml of 0.3% DHEA cream applied on the skin twice daily.

Placebos

Drug

3.0 ml of placebo cream applied on the skin twice daily.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
Nov 4, 2005
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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