Systemic Treatments for Alopecia Areata Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Hair Loss. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Effectiveness of systemic treatments [Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)]
- Safety of systemic treatments [Time frame: A minimum of 10 years from last patient enrolled (every 3-6 months)]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
Inclusion criteria
- Diagnosed with alopecia areata;
- Starting/using a systemic treatment for alopecia areata;
- Informed consent for registry participation obtained from patient and/or caretaker.
Exclusion criteria
- Not sufficiently capable of understanding the Dutch language;
- Not willing to participate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus University Medical Center — Rotterdam
Identifiers
NCT: NCT06283316 · 11347