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NCT Number: NCT06283316

Systemic Treatments for Alopecia Areata Registry

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Effectiveness of systemic treatments

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

    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).

  2. Safety of systemic treatments

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

    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.

Secondary outcomes

  1. Epidemiological data

    Time frame: Baseline

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

  2. Physician Reported - Severity of Alopecia Tool (SALT Score)

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

    The SALT score measures hair loss on a scale of 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  3. Dermatology Life Quality Index (DLQI, 10 items)

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

    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.

  4. Alopecia Areata Symptom Impact Scale (AASIS, 13 items)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

DirkJan Hijnen, MD, PhD

CONTACT

[email protected]

0031 10 704 01 10

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: STA2R

Important dates

Study start
2024
Primary completion
2099
Study completion
2099
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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