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

July 3, 2018 updated by: Wake Forest University
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.

Study Overview

Status

Completed

Conditions

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 erythematosus (DLE). Skin biopsies of five healthy participants will be used as controls.

Study Type

Observational

Enrollment (Actual)

8

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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences Dermatology

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Wake Forest University Health Sciences Dermatology Clinic.

Description

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.

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

Cohorts and Interventions

Group / Cohort
I
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.
II
patients with lichen planopilaris (LP) and patients with discoid lupus erythematosus (DLE) will be collected from patients who have been diagnosed through biopsy in the clinic.
III
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia (CCSA), lichen planopilaris (LP) and discoid lupus erythematosus (DLE) and in healthy controls.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Investigators

  • Principal Investigator: Amy McMichael, MD, Wake Forest University Health Sciences

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 (Actual)

April 26, 2006

Primary Completion (Actual)

November 26, 2012

Study Completion (Actual)

November 26, 2012

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000301
  • 31050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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