ClinicalTrials.Veeva

Menu

Effect of DHEA on Skin Aging in Postmenopausal Women

L

Laval University

Status and phase

Completed
Phase 3

Conditions

Quality of Life
Skin Aging

Treatments

Drug: Placebos
Drug: Dehydroepiandrosterone

Study type

Interventional

Funder types

Other

Identifiers

NCT00248989
ERC-204

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

60 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups

Placebo
Experimental group
Treatment:
Drug: Placebos
DHEA
Experimental group
Treatment:
Drug: Dehydroepiandrosterone

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems