Mechanisms of Skin Repair by Topical Estrogen
1 other identifier
interventional
152
1 country
1
Brief Summary
The purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Collagen is the most abundant protein in human skin and gives skin its strength and shape. Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases collagen production in sun damaged skin. This study will compare the molecular and microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a short-term duration. It is anticipated that the new knowledge from this study will enable development of new ways to improve the function of aged skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 3, 2005
CompletedFirst Posted
Study publicly available on registry
June 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMay 21, 2015
August 1, 2008
2.8 years
June 3, 2005
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue
Interventions
Eligibility Criteria
You may qualify if:
- Healthy post-menopausal (without spontaneous menstrual bleeding for at least 1 year) women, and men, at least 50 years of age and any racial/ethnic type.
- Subjects must understand and sign the informed consent prior to participation.
- Subjects must be in generally good health.
- Subjects must be available for follow-up visits to comply with the requirements of the protocol.
- Not on estrogen replacement therapy within the past 3 months.
- No nonsteroidal anti-inflammatory drugs two weeks prior to study entry.
- No topical steroids two weeks prior to study entry.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
You may not qualify if:
- History of keloid formation or hypertrophic scarring.
- History of reaction to lidocaine anesthetic.
- Subjects with significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation and which would impair evaluation of test sites.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Rittie L, Kang S, Voorhees JJ, Fisher GJ. Induction of collagen by estradiol: difference between sun-protected and photodamaged human skin in vivo. Arch Dermatol. 2008 Sep;144(9):1129-40. doi: 10.1001/archderm.144.9.1129.
PMID: 18794456DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John J Voorhees, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 3, 2005
First Posted
June 6, 2005
Study Start
August 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
May 21, 2015
Record last verified: 2008-08