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Trial record 81 of 239 for:    PRASTERONE

Effect of DHEA on Skin Aging in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00248989
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE November 2, 2005
First Posted Date  ICMJE November 4, 2005
Last Update Posted Date April 7, 2017
Actual Study Start Date  ICMJE November 1, 2004
Actual Primary Completion Date November 24, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2005)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2005)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of DHEA on Skin Aging in Postmenopausal Women
Official Title  ICMJE Effect of DHEA on Skin Aging - Placebo-Controlled and Randomized Phase III Study in Postmenopausal Women.
Brief Summary 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Aging
  • Quality of Life
Intervention  ICMJE
  • Drug: Dehydroepiandrosterone
    3.0 ml of 0.3% DHEA cream applied on the skin twice daily.
  • Drug: Placebos
    3.0 ml of placebo cream applied on the skin twice daily.
Study Arms  ICMJE
  • Experimental: Placebo
    Intervention: Drug: Placebos
  • Experimental: DHEA
    Intervention: Drug: Dehydroepiandrosterone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 13, 2008
Actual Primary Completion Date November 24, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248989
Other Study ID Numbers  ICMJE ERC-204
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonello Cusan, MD, PhD CHUL Research Center
Study Director: Fernand Labrie, MD, PhD CHUL Research Center
PRS Account CHU de Quebec-Universite Laval
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP