Mechanisms of Skin Repair by Topical Estrogen

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00113100
First received: June 3, 2005
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Skin Wrinkling
Drug: Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mechanisms of Skin Repair by Topical Estrogen in Vivo

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue

Enrollment: 152
Study Start Date: August 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113100

Locations
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Study Chair: John J Voorhees, MD University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00113100     History of Changes
Other Study ID Numbers: Derm 530
Study First Received: June 3, 2005
Last Updated: August 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
skin
estrogen
sun damage
Photodamaged Skin

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 21, 2014