Systemic Treatments for Alopecia Areata Registry

NCT ID: NCT06283316

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2099-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

DirkJan Hijnen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

DirkJan Hijnen, MD, PhD

Role: CONTACT

d.hijnen@erasmusmc.nl

0031 10 704 01 10

Facility Contacts

DirkJan Hijnen, MD, PhD

Role: primary

d.hijnen@erasmusmc.nl

0031 10 704 01 10

Other Identifiers

11347

Identifier Type: -

Identifier Source: org_study_id