Systemic Treatments for Alopecia Areata Registry

Autoimmune Diseases Clinical Trial

— STA2R  

Official title:

Systemic Treatments for Alopecia Areata Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283316
• Other study ID #: 11347
• Status: Recruiting
• Start date: January 17, 2024
• Est. completion date: December 31, 2099

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: DirkJan Hijnen, MD, PhD
• Phone: 0031 10 704 01 10
• Email: d.hijnen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2099
• Est. primary completion date: December 31, 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia Drugs
• Alopecia Totalis
• Alopecia Universalis
• Autoimmune Diseases
• Hair Loss

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	A minimum of 10 years from last patient enrolled (every 3-6 months)
Primary	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.	A minimum of 10 years from last patient enrolled (every 3-6 months)
Secondary	Epidemiological data	Demographics, ethiopathogenesis, co-morbidities, family history, clinical features, treatment history.	Baseline
Secondary	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).	A minimum of 10 years from last patient enrolled (every 3-6 months)
Secondary	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.	A minimum of 10 years from last patient enrolled (every 3-6 months)
Secondary	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.	A minimum of 10 years from last patient enrolled (every 3-6 months)