Mechanisms of Skin Repair by Topical Estrogen - Full Text View

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00113100

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Mechanisms of Skin Repair by Topical Estrogen in Vivo

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Propylene glycol Ethanol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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

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 National Clinical Trials Identifier (NCT ID):

Rittié 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.

Study ID Numbers:	Derm 530
Study First Received:	June 3, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00113100 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

skin
estrogen
sun damage
Photodamaged Skin

Study placed in the following topic categories:

Estrogens
Benzoates
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Estradiol 17 beta-cypionate
Hormones
Estradiol
Estradiol 3-benzoate
Polyestradiol phosphate
Ethanol

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate

Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate

ClinicalTrials.gov processed this record on July 02, 2009