Natural History and Pathogenesis of Alopecia in Children and Adults

NCT05502796 | Completed

• 2 other identifiers: 10000827000827-AR
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Loss

Keywords

Skin Conditions; Autoimmune Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• Describe the natural history of alopecia based on demographics, whole exome sequencing, and microbiome and immunologic signals

  5 years

Secondary Outcomes (1)

• Explore immune system, microbiome signals during flares and quiescence as well as during therapy

  5 years

Study Arms (1)

Patient

Male and female ages 2-45 years old

Eligibility Criteria

• Age: 2 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who present in childhood and adulthood with alopecia.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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
• Willing to avoid using antibacterial cleansers for 1 week prior to sampling
• Male or female, aged 2 years and older
• Clinical Diagnosis of immune- mediated alopecia
• Ability of subject or Parent/legal guardian to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Non-immune mediated alopecia including androgenetic alopecia, radiation induced alopecia, trauma induced alopecia, chemotherapy induced alopecia
• Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
• Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.
• Pregnant women

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alopecia; Skin Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Heidi H Kong, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 16, 2022
• Study Start: September 19, 2022
• Primary Completion: January 22, 2025
• Study Completion: January 23, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04-20

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)