Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113100
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-06-03
Brief Title:
Mechanisms of Skin Repair by Topical Estrogen
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Mechanisms of Skin Repair by Topical Estrogen in Vivo
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 estrogenclobetasol 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None