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

Sponsor:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00691769

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:

Genetics Home Reference related topics: androgenetic alopecia

MedlinePlus related topics: Lupus Scars

U.S. FDA Resources

Further study details as provided by Wake Forest University:

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 erythematosous (DLE) and in healthy controls. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

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

Estimated Enrollment:	25
Study Start Date:	April 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (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 erythematosous (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 erythematosous (DLE). Skin biopsies of five healthy participants will be used as controls.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders 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

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

More Information

No publications provided

Responsible Party:	Amy McMichael, MD, 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:	June 10, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Cicatrix
Lichen Planus
Lupus Erythematosus, Discoid
Lupus Erythematosus, Systemic
Hypotrichosis
Hair Diseases
Skin Diseases

Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012