Effect of DHEA on Skin Aging in Postmenopausal Women

NCT00248989 | Completed Phase 3

• 1 other identifier: ERC-204
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging; Quality of Life

Keywords

Skin aging; Menopausal symptoms

Outcome Measures

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.

Study Arms (2)

Placebo

EXPERIMENTAL

Drug: Placebos

DHEA

EXPERIMENTAL

Drug: Dehydroepiandrosterone

Interventions

Dehydroepiandrosterone DRUG

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

DHEA

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Clinique des Traitements Hormonaux- CHUL Research Center

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Related Publications (60)

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  PMID: 18359622 RESULT

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Leonello Cusan, MD, PhD

  CHUL Research Center

  PRINCIPAL INVESTIGATOR

• Fernand Labrie, MD, PhD

  CHUL Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 4, 2005
• Study Start: November 1, 2004
• Primary Completion: November 24, 2005
• Study Completion: November 13, 2008
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)