---
title: Systemic Treatments for Alopecia Areata Registry
nct_id: NCT06283316
overall_status: RECRUITING
sponsor: Erasmus Medical Center
study_type: OBSERVATIONAL
primary_condition: Alopecia Areata
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06283316.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06283316"
ct_last_update_post_date: 2024-02-28
last_seen_at: "2026-05-12T06:40:28.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Systemic Treatments for Alopecia Areata Registry

**NCT ID:** [NCT06283316](https://clinicaltrials.gov/study/NCT06283316)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 10000
- **Lead Sponsor:** Erasmus Medical Center
- **Conditions:** Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Hair Loss, Hair Diseases, Alopecia, Alopecia Drugs, Autoimmune Diseases
- **Start Date:** 2024-01-17
- **Completion Date:** 2099-12-31
- **CT.gov Last Update:** 2024-02-28

## 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

- **Minimum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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

- **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).
- **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

- **Epidemiological data** _(time frame: Baseline)_
- **Physician Reported - Severity of Alopecia Tool (SALT Score)** _(time frame: A minimum of 10 years from last patient enrolled (every 3-6 months))_
- **Dermatology Life Quality Index (DLQI, 10 items)** _(time frame: A minimum of 10 years from last patient enrolled (every 3-6 months))_
- **Alopecia Areata Symptom Impact Scale (AASIS, 13 items)** _(time frame: A minimum of 10 years from last patient enrolled (every 3-6 months))_

## Locations (1)

- Erasmus University Medical Center, Rotterdam, Netherlands — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.erasmus university medical center|rotterdam||netherlands` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06283316*  
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