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

NCT00691769 | Completed

• 2 other identifiers: IRB0000030131050
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Centrifugal Scarring Alopecia; Lichen Planopilaris; Discoid Lupus Erythematosus

Keywords

alopecia; lupus

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• 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.

  8 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Wake Forest University Health Sciences Dermatology Clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two, 4mm punch biopsies will be obtained of skin tissue.

MeSH Terms

Conditions

Lichen Planus; Lupus Erythematosus, Discoid; Alopecia

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy McMichael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 5, 2008
• Study Start: April 26, 2006
• Primary Completion: November 26, 2012
• Study Completion: November 26, 2012
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)