Hair LossNCT05502796
Natural History and Pathogenesis of Alopecia in Children and Adults
An observational study of Hair Loss, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 120 years
- Conditions the study is for
- Hair Loss
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 23 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals who present in childhood and adulthood with alopecia.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Study Description:
This is a study to detail the characteristics (genetic, immunologic, biological and demographic) of individuals who present in childhood and adulthood with alopecia and how alopecia impacts skin and systemic symptoms.
Objectives:
Primary objective: Comprehensively evaluate patients with immune mediated alopecia from clinical, microbiome, immunologic and genetic standpoint to understand the factors that contribute to clinical phenotypes.
Secondary objective: To follow patients with immune-mediated alopecia to see how disease impacts local skin microbiome, immune system changes and autoimmune and other comorbidities.
Tertiary objectives: To develop prognostic biomarkers that help predict the risk of severity and progression in patients with alopecia.
Endpoints:
- Record demographics including age, sex, age of onset, severity of disease based on clinical examination, concomitant autoimmune disease, personal history of other medical disease including anxiety and depression, family history of autoimmune and medical disease
- Whole genome sequencing to identify variations in the protein-coding region of any gene that may be disease causing
- Assess peripheral blood and local scalp skin to assess immunogenicity of disease by using leukocyte subset analysis using flow cytometry, markers of disease using cytokine signaling assays, and single cell RNA sequencing
- Define skin microbiome using sequencing at baseline and with time.
- Identify potential biomarkers of disease progression or severity that may impact therapeutic choices
- Conditions
- Hair Loss
- Keywords
- Skin Conditions, Autoimmune Disease, Natural History
- Medical subject headings
- Alopecia, Skin Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Male and female ages 2-45 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the natural history of alopecia based on demographics, whole exome sequencing, and microbiome and immunologic signals
Measured: 5 years
Secondary outcomes (1)
Explore immune system, microbiome signals during flares and quiescence as well as during therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start19 Sep 2022
- Primary completion22 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Heidi H Kong, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502796
- Sponsor's protocol ID
- 10000827
- Other IDs
- 000827-AR
- Status last verified
- 2 Nov 2026
- First submitted
- 13 Aug 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Pathogenesis of Alopecia in Children and Adults
- ClinicalTrials.gov ID
- NCT05502796
- Acronym / sponsor ID
- 10000827
- Conditions
- Hair Loss
- Keywords
- Skin Conditions, Autoimmune Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
This is a study to detail the characteristics (genetic, immunologic, biological and demographic) of individuals who present in childhood and adulthood with alopecia and how alopecia impacts skin and systemic symptoms.
Objectives:
Primary objective: Comprehensively evaluate patients with immune mediated alopecia from clinical, microbiome, immunologic and genetic standpoint to understand the factors that contribute to clinical phenotypes.
Secondary objective: To follow patients with immune-mediated alopecia to see how disease impacts local skin microbiome, immune system changes and autoimmune and other comorbidities.
Tertiary objectives: To develop prognostic biomarkers that help predict the risk of severity and progression in patients with alopecia.
Endpoints:
- Record demographics including age, sex, age of onset, severity of disease based on clinical examination, concomitant autoimmune disease, personal history of other medical disease including anxiety and depression, family history of autoimmune and medical disease
- Whole genome sequencing to identify variations in the protein-coding region of any gene that may be disease causing
- Assess peripheral blood and local scalp skin to assess immunogenicity of disease by using leukocyte subset analysis using flow cytometry, markers of disease using cytokine signaling assays, and single cell RNA sequencing
- Define skin microbiome using sequencing at baseline and with time.
- Identify potential biomarkers of disease progression or severity that may impact therapeutic choices
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Male and female ages 2-45 years old |
Who may qualify
- Ages
- 2 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who present in childhood and adulthood with alopecia.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the natural history of alopecia based on demographics, whole exome sequencing, and microbiome and immunologic signals
Time frame: 5 years
1 secondary outcome
Explore immune system, microbiome signals during flares and quiescence as well as during therapy
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hair Loss
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi H Kong, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hair Loss, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the natural history of alopecia based on demographics, whole exome sequencing, and microbiome and immunologic signals (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.