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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amy McMichael, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00691769
First received: June 2, 2008
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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.

Condition
Central Centrifugal Scarring Alopecia
Lichen Planopilaris
Discoid Lupus Erythematosus

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Two, 4mm punch biopsies will be obtained of skin tissue.

Enrollment: 8
Actual Study Start Date: April 26, 2006
Study Completion Date: November 26, 2012
Primary Completion Date: November 26, 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Wake Forest University Health Sciences Dermatology Clinic.
Criteria

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.
  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: NCT00691769

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Amy McMichael, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Amy McMichael, Professor of Dermatology, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00691769     History of Changes
Other Study ID Numbers: 00000301
31050
Study First Received: June 2, 2008
Last Updated: January 24, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences:
alopecia
lupus

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Cicatrix
Lupus Erythematosus, Discoid
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases

ClinicalTrials.gov processed this record on March 30, 2017