Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia - Tabular View

Tracking Information

First Received Date ^ICMJE

June 2, 2008

Last Updated Date

June 10, 2008

Start Date ^ICMJE

April 2006

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia (CCSA), lichen planopilaris (LP) and discoid lupus erythematosous (DLE) and in healthy controls. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00691769 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia before and after treatment with intralesional and topical steroids. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia

Official Title ^ICMJE

Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia

Brief Summary

The purpose of this research study is to see if a specific protein that we are interested in is involved in scarring hair loss. If these proteins are involved, further genetic work may also better define the disease as well as future treatment options.

Detailed Description

This is a single-center study, designed to evaluate the expression of Fas protein in skin biopsies of patients with scarring alopecia including fourteen patients with central centrifugal scarring alopecia (CCSA), three patients with lichen planopilaris (LP) and three patients with discoid lupus erythematosous (DLE). Skin biopsies of five healthy participants will be used as controls.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Central Centrifugal Scarring Alopecia
Lichen Planopilaris
Discoid Lupus Erythematosus

Intervention ^ICMJE

Study Arms / Comparison Groups

CCSA subjects will be recruited from patients who have been diagnosed through biopsy with CCSA and treated with standard of care for up to eight months in the Department of Dermatology clinic of Wake Forest University School of Medicine.
patients with lichen planopilaris (LP) and patients with discoid lupus erythematosous (DLE) will be collected from patients who have been diagnosed through biopsy in the clinic.
Healthy study subjects will be patients from the Wake Forest University School of Medicine Department of Dermatology population undergoing excisions for cosmetic purposes or excision of free margins around tumors that would have otherwise been discarded.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participants ages 30 years or older with a biopsy- proven diagnosis of CCSA.
Undergone standard of care treatment for CCSA by a WFUSM Dermatologist
Women of child bearing age will be required to have a negative pregnancy test in order to participate in the study
Participants ages 30 years or older with a biopsy- proven diagnosis of LP.
Participants ages 30 years or older with a biopsy- proven diagnosis of DLE.
Healthy participants must be ages 30 years or older.

Exclusion Criteria:

Age less than 30 years of age.
Clinically evident bacterial or viral infection of the scalp.
Pregnant or nursing woman of child-bearing potential.
Participation in any other investigative research study involving study medication.
Inability to return for the biopsy visit.

Gender

Female

Ages

30 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00691769

Responsible Party

Amy McMichael, MD, Wake Forest University Health Sciences

Study ID Numbers ^ICMJE

00000301, 31050

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Amy McMichael, MD

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP