Alopecia AreataSTA2RNCT06283316
Systemic Treatments for Alopecia Areata Registry
An observational study of Alopecia Areata and Alopecia Totalis, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jan 2024to 31 Dec 2099
- How long will I take part?
- 50 Years
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult patients with alopecia areata starting/using systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry. All patients will be recruited in the dermatology outpatient clinics.
Who may be able to join
- Diagnosed with alopecia areata;
- Starting/using a systemic treatment for alopecia areata;
- Informed consent for registry participation obtained from patient and/or caretaker.
Who cannot join
- Not sufficiently capable of understanding the Dutch language;
- Not willing to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam
DirkJan Hijnen, MD, PhD, 0031 10 704 01 10, d.hijnen@erasmusmc.nl
About this study
A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.
Read the detailed description
Rationale:
Alopecia areata (AA) is a dermatological disorder characterized by non-scarring hair loss, significantly affecting the quality of life of patients. While some patients experience spontaneous hair regrowth or respond well to localized treatments, patients with moderate-to-severe AA represent a subgroup that requires more extensive systemic therapies for effective management. Currently, the clinical management of moderate-to-severe AA is primarily based on expert opinions. There is a lack of research on systemic treatments for moderate-to-severe AA, comprising only a small number of randomized controlled trials and observational studies. Furthermore, there is a clear absence of long-term, prospective, and comparative data on these therapies. Most conventional systemic treatments for AA are prescribed off-label, underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety.
Therefore, a long-term prospective registry is conducted. This registry will evaluate the real-world utilization of systemic treatments in AA patients, aiming to provide valuable insights into the effectiveness, safety, and long-term outcomes of these therapies. By collecting and analyzing such data, this registry endeavors to contribute to evidence-based clinical management, ultimately improving care for AA patients.
Objective:
The aim is to establish a comprehensive cohort of AA patients receiving systemic treatments, with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for AA.
Study type:
This is a long-term multicenter prospective, observational, non-interventional registry.
Study population:
All adult AA patients starting systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry.
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Hair Loss, Hair Diseases, Alopecia
- Keywords
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Systemic treatment, Registry
- Medical subject headings
- Alopecia Areata, Alopecia universalis, Alopecia, Hair Diseases, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of systemic treatments
The primary study parameters and endpoints include assessing the short- and long-term effectiveness of various systemic treatments for alopecia areata. Effectiveness ranging from strong improvement to strong deterioration (5 categories).
Measured: A minimum of 10 years from last patient enrolled (every 3-6 months)
Safety of systemic treatments
The primary study parameters and endpoints include assessing the short- and long-term safety of various systemic treatments for alopecia areata. Measured by the number of participants with treatment-related adverse events.
Measured: A minimum of 10 years from last patient enrolled (every 3-6 months)
Secondary outcomes (4)
Epidemiological data
Demographics, ethiopathogenesis, co-morbidities, family history, clinical features, treatment history.
Measured: Baseline
Physician Reported - Severity of Alopecia Tool (SALT Score)
The SALT score measures hair loss on a scale of 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Measured: A minimum of 10 years from last patient enrolled (every 3-6 months)
Dermatology Life Quality Index (DLQI, 10 items)
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week, scored 0-30.
Measured: A minimum of 10 years from last patient enrolled (every 3-6 months)
Alopecia Areata Symptom Impact Scale (AASIS, 13 items)
The AASIS consists of 13 questions concerning disease-specific patient-reported outcomes measure about symptoms related to alopecia areata and how these symptoms interfere with daily functioning.
Measured: A minimum of 10 years from last patient enrolled (every 3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start17 Jan 2024
- Primary completion31 Dec 2099 (estimated)
- Study completion31 Dec 2099 (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 Erasmus Medical 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DirkJan Hijnen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283316
- Sponsor's protocol ID
- 11347
- Acronym
- STA2R
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Treatments for Alopecia Areata Registry
- ClinicalTrials.gov ID
- NCT06283316
- Acronym / sponsor ID
- STA2R / 11347
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Hair Loss, Hair Diseases, Alopecia
- Keywords
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Systemic treatment, Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 28 Feb 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.
A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.
Detailed description
Rationale:
Alopecia areata (AA) is a dermatological disorder characterized by non-scarring hair loss, significantly affecting the quality of life of patients. While some patients experience spontaneous hair regrowth or respond well to localized treatments, patients with moderate-to-severe AA represent a subgroup that requires more extensive systemic therapies for effective management. Currently, the clinical management of moderate-to-severe AA is primarily based on expert opinions. There is a lack of research on systemic treatments for moderate-to-severe AA, comprising only a small number of randomized controlled trials and observational studies. Furthermore, there is a clear absence of long-term, prospective, and comparative data on these therapies. Most conventional systemic treatments for AA are prescribed off-label, underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety.
Therefore, a long-term prospective registry is conducted. This registry will evaluate the real-world utilization of systemic treatments in AA patients, aiming to provide valuable insights into the effectiveness, safety, and long-term outcomes of these therapies. By collecting and analyzing such data, this registry endeavors to contribute to evidence-based clinical management, ultimately improving care for AA patients.
Objective:
The aim is to establish a comprehensive cohort of AA patients receiving systemic treatments, with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for AA.
Study type:
This is a long-term multicenter prospective, observational, non-interventional registry.
Study population:
All adult AA patients starting systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients with alopecia areata starting/using systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry. All patients will be recruited in the dermatology outpatient clinics.
Key inclusion criteria (3 listed)
- Diagnosed with alopecia areata;
- Starting/using a systemic treatment for alopecia areata;
- Informed consent for registry participation obtained from patient and/or caretaker.
Key exclusion criteria (2 listed)
- Not sufficiently capable of understanding the Dutch language;
- Not willing to participate.
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
Effectiveness of systemic treatments
Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)
The primary study parameters and endpoints include assessing the short- and long-term effectiveness of various systemic treatments for alopecia areata. Effectiveness ranging from strong improvement to strong deterioration (5 categories).
Safety of systemic treatments
Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)
The primary study parameters and endpoints include assessing the short- and long-term safety of various systemic treatments for alopecia areata. Measured by the number of participants with treatment-related adverse events.
4 secondary outcomes
Epidemiological data
Time frame: Baseline
Physician Reported - Severity of Alopecia Tool (SALT Score)
Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)
Dermatology Life Quality Index (DLQI, 10 items)
Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)
Alopecia Areata Symptom Impact Scale (AASIS, 13 items)
Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)
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 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 and Alopecia Totalis, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 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: looking for participants now, as of the sponsor's last update on 28 Feb 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 Netherlands. 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?
Contact DirkJan Hijnen, MD, PhD (0031 10 704 01 10, d.hijnen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of systemic treatments (time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)). The study lists 2 primary outcomes in all. 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 28 Feb 2024.