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Protocol Details

Natural History and Pathogenesis of Alopecia in Children and Adults

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000827-AR

Sponsoring Institute

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Adults who are or may become unable to consent;
Pregnant Women

Keywords

Skin Conditions;
Autoimmune Disease;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Hair Loss

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Background:

Alopecia is the loss of hair or lack of hair growth. It is often related to an immune disorder that disrupts the growth of hair. Hair loss can affect a person s physical and mental health. The causes of alopecia are not well understood. This natural history study will examine causes of alopecia so better treatments can be developed.

Objective:

To learn why some people have alopecia. This study will look at factors related to genes, the immune system, and the bacteria, viruses, and fungi that live on the skin.

Eligibility:

People aged 2 years and older with immune-mediated alopecia that affects 50% of their scalp hair.

Design:

Participants will have at least 1 visit to the clinic. Some will have follow-up visits once a year for up to 5 years. Each visit will last 2 to 4 hours.

Participants will have a physical exam. They will have blood drawn from a vein. They will answer questions about the medications they take, their allergies, and their family history. Photographs of their skin and scalp will be taken. Soft cotton swabs will be rubbed on their skin to pick up organisms that live there.

Two pieces of skin from the scalp will be cut away. The pieces will be no more than a quarter of an inch in size. The area will first be numbed with an injectable anesthetic. The wound will be closed with stitches or gel foam. The biopsy is optional in children younger than 12.

Participants will take a questionnaire about how hair loss affects their quality of life.

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Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with study procedures including skin biopsy of the scalp (except in those under the age of 12 years) and availability for the duration of the study

2. Willing to avoid using antibacterial cleansers for 1 week prior to sampling

3. Male or female, aged 2 years and older

4. Clinical Diagnosis of immune- mediated alopecia

5. Ability of subject or Parent/legal guardian to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

1. Non-immune mediated alopecia including androgenetic alopecia, radiation induced alopecia, trauma induced alopecia, chemotherapy induced alopecia

2. Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.

3. Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.

4. Pregnant women


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leslie A. Castelo-Soccio, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIHBC 10 - CLINICAL CENTER BG RM 13C429
10 CENTER DR
BETHESDA MD 20892
(301) 594-3457
leslie.castelo-soccio@nih.gov

Monica Taylor, R.N.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
Building 10
Room 13C429A
10 Center Drive
Bethesda, Maryland 20892
(301) 451-2221
monica.taylor@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05502796

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