Systemic Treatments for Alopecia Areata Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorErasmus Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with alopecia areata;

Starting/using a systemic treatment for alopecia areata;

Informed consent for registry participation obtained from patient and/or caretaker.

Disqualifiers

Not sufficiently capable of understanding the Dutch language;

Not willing to participate.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
A minimum of 10 years from last patient enrolled (every 3-6 months)
2

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.

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

Secondary outcomes

1

Epidemiological data

Demographics, ethiopathogenesis, co-morbidities, family history, clinical features, treatment history.

Time frame
Baseline
2

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).

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

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.

Time frame
A minimum of 10 years from last patient enrolled (every 3-6 months)
4

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.

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

Other outcomes

Sponsors and contacts

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