Alopecia AreataNAARNCT00069589
Alopecia Areata Registry
An observational study of Alopecia Areata and Alopecia Totalis, run by M.D. Anderson Cancer Center at 5 sites in United States.
Trial summary
Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- How many people
- 3,100 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2001to Nov 2099
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with alopecia areata (AA), both children and adults, who have been diagnosed by a physician with alopecia universalis, alopecia totalis, patchy persistent AA, or transient mild AA. Family members (related by blood) of these patients, preferably sib-pairs plus parents and multiplex families(persons with at least three family members with AA or alopecia universalis and alopecia totalis). Also, healthy individuals who are unaffected, non-blood related individuals and do not live in the same household with alopecia areata patient are needed as controls.
Who may be able to join
- Diagnosed with alopecia areata by a dermatologist
- United States resident
- Accepts Health Volunteers: Non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado - UCHSC - Health Science Center at Fitzsimons
Aurora, Colorado, 80010-7163
M.D. Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University
New York, New York, 10032
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Alopecia Areata Registry and Immunogenetic Mechanisms
Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata.
Read the detailed description
Alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. It is thought to be an autoimmune disease and in some cases the disease is hereditary. The Alopecia Areata Registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). This will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). Information from these patients will be used to search the human genome for disease-associated loci and/or genes. Researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question.
Patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. Patients will fill out an information form online (alopeciaareataregistry.org). Patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn.
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Autoimmune Hair Loss, Alopecia Partialis
- Keywords
- Baldness, Autoimmunity, Hair, Alopecia Areata, Alopecia Partialis, Alopecia Totalis, Alopecia Universalis, Autoimmune Hair Loss
- Medical subject headings
- Alopecia Areata, Alopecia universalis, Alopecia, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Alopecia Areata Registry
Database registration of participants via collection of participant epidemiology data.
Measured: Registration on-going
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2003 (estimated)
- Study startNov 2001
- Primary completionNov 2099 (estimated)
- Study completionNov 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Alopecia Areata Foundation
- Responsible party
- Sponsor
- Investigators
- Madeleine Duvic, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069589
- Sponsor's protocol ID
- NIAMS-097
- Other IDs
- HHSN268200682279C
- Acronym
- NAAR
- Status last verified
- May 2019
- First submitted
- 29 Sep 2003
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duvic M, Norris D, Christiano A, Hordinsky M, Price V. Alopecia areata registry: an overview. J Investig Dermatol Symp Proc. 2003 Oct;8(2):219-21. doi: 10.1046/j.1087-0024.2003.00814.x.
PubMed 14582678Barahmani N, Yang Y, Lopez A, Duvic M. Atopic alopecia areata patients have increased serum Th1 Cytokine profiles. 66th Annual meeting of Society for Investigative Dermatology. St.Louis, MO, May 2005. JID 124 (4): A100, 2005.
Breuer-McHam J, Hunzicker K, Barahmani N, Zhang Q, Babu D, Christiano A, Hordinsky M, Norris D, Price V, Duvic, M. Epidemiologic and disease associations in participants of the national alopecia areata (NAAR) registrants. Accepted by Society for Investigational Dermatology, April 12, 2004. JID 122 (3): A107, 2004.
de Andrade M, Barahmani N, Hunzicker K, Zhang Q, Joan Breuer- McHam, Joyce Osei, Daniel Babu, Qingyi Wei, Reveille J, Duvic M. HLA Class II associations confirm alopecia areata phenotypic subsets. 66th Annual meeting of Society for Investigative Dermatology. St. Louis, MO, May 2005.JID 124 (4): A107, 2005.
Barahmani N, de Andrade M, Slusser JP, Wei Q, Hordinsky M, Price VH, Christiano A, Norris D, Reveille J, Duvic M. Human leukocyte antigen class II alleles are associated with risk of alopecia areata. J Invest Dermatol. 2008 Jan;128(1):240-3. doi: 10.1038/sj.jid.5700973. Epub 2007 Jul 19. No abstract available.
PubMed 17637820Ahmed AM, Barahmani N, Duvic M; National Alopecia Areata Registry. Familial alopecia areata and chronic thrombocytopenia. J Am Acad Dermatol. 2008 May;58(5 Suppl 1):S75-7. doi: 10.1016/j.jaad.2007.05.017.
PubMed 18489053Rodriguez TA, Duvic M; National Alopecia Areata Registry. Onset of alopecia areata after Epstein-Barr virus infectious mononucleosis. J Am Acad Dermatol. 2008 Jul;59(1):137-9. doi: 10.1016/j.jaad.2008.02.005. Epub 2008 Mar 7.
PubMed 18329131Martinez-Mir A, Zlotogorski A, Gordon D, Petukhova L, Mo J, Gilliam TC, Londono D, Haynes C, Ott J, Hordinsky M, Nanova K, Norris D, Price V, Duvic M, Christiano AM. Genomewide scan for linkage reveals evidence of several susceptibility loci for alopecia areata. Am J Hum Genet. 2007 Feb;80(2):316-28. doi: 10.1086/511442. Epub 2007 Jan 5.
PubMed 17236136Barahmani N, de Andrade M, Slusser JP, Zhang Q, Duvic M. Major histocompatibility complex class I chain-related gene A polymorphisms and extended haplotypes are associated with familial alopecia areata. J Invest Dermatol. 2006 Jan;126(1):74-8. doi: 10.1038/sj.jid.5700009.
PubMed 16417220
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alopecia Areata Registry and Immunogenetic Mechanisms
- ClinicalTrials.gov ID
- NCT00069589
- Acronym / sponsor ID
- NAAR / NIAMS-097
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Autoimmune Hair Loss, Alopecia Partialis
- Keywords
- Baldness, Autoimmunity, Hair, Alopecia Areata, Alopecia Partialis, Alopecia Totalis, Alopecia Universalis, Autoimmune Hair Loss
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Alopecia Areata Foundation
- Study start
- Nov 2001
- Primary completion
- Nov 2099 (estimated)
- Study completion
- Nov 2099 (estimated)
- First posted
- 30 Sep 2003 (estimated)
- 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.
Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata.
Detailed description
Alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. It is thought to be an autoimmune disease and in some cases the disease is hereditary. The Alopecia Areata Registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). This will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). Information from these patients will be used to search the human genome for disease-associated loci and/or genes. Researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question.
Patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. Patients will fill out an information form online (alopeciaareataregistry.org). Patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with alopecia areata (AA), both children and adults, who have been diagnosed by a physician with alopecia universalis, alopecia totalis, patchy persistent AA, or transient mild AA. Family members (related by blood) of these patients, preferably sib-pairs plus parents and multiplex families(persons with at least three family members with AA or alopecia universalis and alopecia totalis). Also, healthy individuals who are unaffected, non-blood related individuals and do not live in the same household with alopecia areata patient are needed as controls.
Key inclusion criteria (3 listed)
- Diagnosed with alopecia areata by a dermatologist
- United States resident
- Accepts Health Volunteers: Non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient.
Key exclusion criteria (0 listed)
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
Alopecia Areata Registry
Time frame: Registration on-going
Database registration of participants via collection of participant epidemiology data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Results publication: PubMed 14582678Duvic M, Norris D, Christiano A, Hordinsky M, Price V. Alopecia areata registry: an overview. J Investig Dermatol Symp Proc. 2003 Oct;8(2):219-21. doi: 10.1046/j.1087-0024.2003.00814.x.
- Results publicationBarahmani N, Yang Y, Lopez A, Duvic M. Atopic alopecia areata patients have increased serum Th1 Cytokine profiles. 66th Annual meeting of Society for Investigative Dermatology. St.Louis, MO, May 2005. JID 124 (4): A100, 2005.
- Results publicationBreuer-McHam J, Hunzicker K, Barahmani N, Zhang Q, Babu D, Christiano A, Hordinsky M, Norris D, Price V, Duvic, M. Epidemiologic and disease associations in participants of the national alopecia areata (NAAR) registrants. Accepted by Society for Investigational Dermatology, April 12, 2004. JID 122 (3): A107, 2004.
- Results publicationde Andrade M, Barahmani N, Hunzicker K, Zhang Q, Joan Breuer- McHam, Joyce Osei, Daniel Babu, Qingyi Wei, Reveille J, Duvic M. HLA Class II associations confirm alopecia areata phenotypic subsets. 66th Annual meeting of Society for Investigative Dermatology. St. Louis, MO, May 2005.JID 124 (4): A107, 2005.
- Results publication: PubMed 17637820Barahmani N, de Andrade M, Slusser JP, Wei Q, Hordinsky M, Price VH, Christiano A, Norris D, Reveille J, Duvic M. Human leukocyte antigen class II alleles are associated with risk of alopecia areata. J Invest Dermatol. 2008 Jan;128(1):240-3. doi: 10.1038/sj.jid.5700973. Epub 2007 Jul 19. No abstract available.
- Results publication: PubMed 18489053Ahmed AM, Barahmani N, Duvic M; National Alopecia Areata Registry. Familial alopecia areata and chronic thrombocytopenia. J Am Acad Dermatol. 2008 May;58(5 Suppl 1):S75-7. doi: 10.1016/j.jaad.2007.05.017.
- Results publication: PubMed 18329131Rodriguez TA, Duvic M; National Alopecia Areata Registry. Onset of alopecia areata after Epstein-Barr virus infectious mononucleosis. J Am Acad Dermatol. 2008 Jul;59(1):137-9. doi: 10.1016/j.jaad.2008.02.005. Epub 2008 Mar 7.
- Results publication: PubMed 17236136Martinez-Mir A, Zlotogorski A, Gordon D, Petukhova L, Mo J, Gilliam TC, Londono D, Haynes C, Ott J, Hordinsky M, Nanova K, Norris D, Price V, Duvic M, Christiano AM. Genomewide scan for linkage reveals evidence of several susceptibility loci for alopecia areata. Am J Hum Genet. 2007 Feb;80(2):316-28. doi: 10.1086/511442. Epub 2007 Jan 5.
- Results publication: PubMed 16417220Barahmani N, de Andrade M, Slusser JP, Zhang Q, Duvic M. Major histocompatibility complex class I chain-related gene A polymorphisms and extended haplotypes are associated with familial alopecia areata. J Invest Dermatol. 2006 Jan;126(1):74-8. doi: 10.1038/sj.jid.5700009.
- National Alopecia Areata Foundation (NAAF) official websiteLink provided by the sponsor.
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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.
Madeleine Duvic, MD principal investigator
M.D. Anderson Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia Areata and Alopecia Totalis, run by M.D. Anderson Cancer Center at 5 sites 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 3 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Alopecia Areata Registry (time frame: Registration on-going). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00069589, which also lists 9 linked publications.
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 14 May 2019.