- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00113100
Mechanisms of Skin Repair by Topical Estrogen
May 20, 2015 updated by: University of Michigan
Mechanisms of Skin Repair by Topical Estrogen in Vivo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objectives of the study are to determine if topically-applied 17-beta estradiol (E2), alone or in combination with clobetasol, will produce histological and molecular effects distinguishable from vehicle in human skin.
Specifically, the study will focus on regulation of collagen, elastin, and hyaluronic acid production and degradation in human skin, by steroid hormone receptors that are activated by estrogen or clobetasol.
The sites to be treated will be buttock, hip, forearm, or facial skin.
Subjects will receive between one to twelve vehicle (matching solution without any active ingredients), estrogen, and/or clobetasol topical applications.
Skin biopsies of treated areas will be obtained at baseline and at subsequent timepoints.
The study will last up to two weeks.
Endpoints will include protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue.
In addition, we will perform cDNA microanalysis to determine estrogen/clobetasol target genes in human skin.
The results from our studies will provide new knowledge regarding the molecular basis of skin aging.
This new knowledge will enable development of new ways to improve the function of aged skin.
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
June 3, 2005
First Submitted That Met QC Criteria
June 3, 2005
First Posted (Estimate)
June 6, 2005
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Ethanol
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- Derm 530
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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