Systemic Treatments for Alopecia Areata Registry (STA2R)

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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: DirkJan Hijnen, MD, PhD; Phone Number: 0031 10 704 01 10; Email: d.hijnen@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus University Medical Center
    • Contact: DirkJan Hijnen, MD, PhD; Phone Number: 0031 10 704 01 10; Email: d.hijnen@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiological data	Demographics, ethiopathogenesis, co-morbidities, family history, clinical features, treatment history.	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).	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.	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.	A minimum of 10 years from last patient enrolled (every 3-6 months)

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Registry; Alopecia Areata; Alopecia Universalis; Alopecia Totalis; Systemic treatment
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Autoimmune Diseases; Alopecia; Alopecia Areata; Hair Diseases
• Other Study ID Numbers: 11347 (DAIDS ES)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No