Systemic Treatments for Alopecia Areata Registry

NCT06283316 | Recruiting

• 1 other identifier: 11347
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Alopecia Areata; Alopecia Totalis; Alopecia Universalis; Systemic treatment; Registry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Epidemiological data

  Baseline

• Physician Reported - Severity of Alopecia Tool (SALT Score)

  A minimum of 10 years from last patient enrolled (every 3-6 months)

• Dermatology Life Quality Index (DLQI, 10 items)

  A minimum of 10 years from last patient enrolled (every 3-6 months)

• Alopecia Areata Symptom Impact Scale (AASIS, 13 items)

  A minimum of 10 years from last patient enrolled (every 3-6 months)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with alopecia areata;
• Starting/using a systemic treatment for alopecia areata;
• Informed consent for registry participation obtained from patient and/or caretaker.

You may not qualify if:

• Not sufficiently capable of understanding the Dutch language;
• Not willing to participate.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis; Alopecia; Hair Diseases; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Hypotrichosis; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Central Study Contacts

DirkJan Hijnen, MD, PhD

CONTACT

0031 10 704 01 10; d.hijnen@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: January 17, 2024
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (1)