Clinical trial NCT06283316: Systemic Treatments for Alopecia Areata Registry
Official title: Systemic Treatments for Alopecia Areata Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Effectiveness of systemic treatments
timeFrame: A minimum of 10 years from last patient enrolled (every 3-6 months)
measure: Safety of systemic treatments
timeFrame: A minimum of 10 years from last patient enrolled (every 3-6 months)
Secondary outcomes:
measure: Epidemiological data
timeFrame: Baseline
measure: Physician Reported - Severity of Alopecia Tool (SALT Score)
timeFrame: A minimum of 10 years from last patient enrolled (every 3-6 months)
measure: Dermatology Life Quality Index (DLQI, 10 items)
timeFrame: A minimum of 10 years from last patient enrolled (every 3-6 months)
measure: Alopecia Areata Symptom Impact Scale (AASIS, 13 items)
timeFrame: A minimum of 10 years from last patient enrolled (every 3-6 months)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
References: