Systemic Treatments for Alopecia Areata Registry

Recruiting

• Conditions: Alopecia Universalis; Alopecia; Autoimmune Diseases; Alopecia Areata; Alopecia Drugs; Hair Loss; Hair Diseases; Alopecia Totalis

• Registration Number: NCT06283316
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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 Timeline

• Study Start: 2024-01-17
• Status Verified: 2024-02
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2099-12-31
• Study Completion: 2099-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of systemic treatments	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.
Effectiveness of systemic treatments	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).

Secondary Outcome Measures

Name	Time	Method
Physician Reported - Severity of Alopecia Tool (SALT Score)	A minimum of 10 years from last patient enrolled (every 3-6 months)	The SALT score measures hair loss on a scale of 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Epidemiological data	Baseline	Demographics, ethiopathogenesis, co-morbidities, family history, clinical features, treatment history.
Dermatology Life Quality Index (DLQI, 10 items)	A minimum of 10 years from last patient enrolled (every 3-6 months)	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.
Alopecia Areata Symptom Impact Scale (AASIS, 13 items)	A minimum of 10 years from last patient enrolled (every 3-6 months)	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.

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands