Alopecia AreataESTAANCT06471114
Evaluation of the Efficacy of Systemic Treatments for Alopecia (ESTAA)
An observational study of Alopecia Areata, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 30 Oct 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients selected from 5 university hospitals in the HUGO network (Brest, Rennes, Tours, Angers, Nantes).
Who may be able to join
- Patient with severe alopecia
- Has received at least one systemic treatment for at least 3 months (among methotrexate, intravenous or oral corticosteroid therapy, Ciclosporin, UVA/UVB phototherapy)
- Patient affiliated to a social security scheme
- Age greater than or equal to 18 years
Who cannot join
- Patients under legal protection (guardianship, curatorship, etc.)
- Refusal to participate
- Other cause of alopecia
- Follow-up less than 3 months
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Systemic Treatments for Alopecia
The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours.
- Conditions
- Alopecia Areata
- Keywords
- severe
- Medical subject headings
- Alopecia Areata, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term efficacy and security of systemic treatments
Response rates including complete response or partial response or no response for each modality of treatment. and Side effects rate
Measured: From January 2010 to December 2020
Secondary outcomes (1)
Long-term efficacy of systemic treatments
Among responders (CR and PR), the maintained response rate and relapse rate
Measured: From January 2010 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Nov 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471114
- Sponsor's protocol ID
- 29BRC23.0239 - ESTAA
- Acronym
- ESTAA
- Status last verified
- Oct 2023
- First submitted
- 29 Apr 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Systemic Treatments for Alopecia
- ClinicalTrials.gov ID
- NCT06471114
- Acronym / sponsor ID
- ESTAA / 29BRC23.0239 - ESTAA
- Conditions
- Alopecia Areata
- Keywords
- severe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Jun 2024 (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.
The aim of our study was to retrospectively assess the efficacy and safety of systemic treatments in patients with alopecia areata, by recruiting cases from the HUGO network (Hôpitaux Universitaires du Grand Ouest), a network of 5 hospitals : Brest, Nantes, Rennes, Angers and Tours.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients selected from 5 university hospitals in the HUGO network (Brest, Rennes, Tours, Angers, Nantes).
Key inclusion criteria (4 listed)
- Patient with severe alopecia
- Has received at least one systemic treatment for at least 3 months (among methotrexate, intravenous or oral corticosteroid therapy, Ciclosporin, UVA/UVB phototherapy)
- Patient affiliated to a social security scheme
- Age greater than or equal to 18 years
Key exclusion criteria (5 listed)
- Patients under legal protection (guardianship, curatorship, etc.)
- Refusal to participate
- Other cause of alopecia
- Follow-up less than 3 months
- Age under 18 years
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
Short-term efficacy and security of systemic treatments
Time frame: From January 2010 to December 2020
Response rates including complete response or partial response or no response for each modality of treatment. and Side effects rate
1 secondary outcome
Long-term efficacy of systemic treatments
Time frame: From January 2010 to December 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alopecia Areata, run by University Hospital, Brest at 1 site in France.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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 France. 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?
Results are not available in the source record.
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?
Short-term efficacy and security of systemic treatments (time frame: From January 2010 to December 2020). 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 24 Jun 2024.