A Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorAbbVie

About this trial

This study is to assess the burden of disease in adolescent and adult participants with moderate or severe alopecia areata (AA), non-segmental vitiligo (NSV), or moderate to severe hidradenitis suppurativa (HS) in a large global real-world participant population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with Physician-confirmed diagnosis of non-segmental vitiligo (NSV), moderate to severe Alopecia Areata (AA), or moderate to severe hidradenitis suppurativa (HS)

Participants Ability to understand study questionnaires, with caregiver support as required for adolescents

Disqualifiers

Participating in interventional clinical trial(s) at time of study visit (participation in another non-interventional study or registry does not exclude a participant from this study)

Unable or unwilling to comply with study requirements and PRO collection

Trial population

Adolescent and Adult Participants with Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa in Real-World will undergo a single-visit data collection per routine clinical practice.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

2,795 Participants
are grouped into 3 trial groups
Group A: Participants with Vitiligo
Group B: Participants with Alopecia Areata
Group C: Participants with Hidradenitis Suppurativa

Trial outcomes

Primary outcomes

1

Alopecia Areata (AA) symptoms affecting quality of life and daily functioning, assessed by the Alopecia Areata Symptom Impact Scale (AASIS) AA only

AASIS- is a scale assessing the severity of AA-related symptoms on daily functioning. Each item scored on a 0-10 Likert scale, where 0 = not present and 10 = as bad as you can imagine Higher total score = greater impact

Time frame
Up to Day 1
2

Measuring scalp hair loss, assessed by the Severity of Alopecia Tool (SALT) score. AA only

SALT is a Tool developed to quantify AA-related hair loss Total score of 0-100, with 0 = no hair loss, and 100 = complete hair loss

Time frame
Up to Day 1
3

Measuring facial skin depigmentation, assessed by the Facial Vitiligo Area Scoring Index (F-VASI) Vitiligo Only

F-VASI is a quantitative scoring tool used to evaluate the extent and severity of facial vitiligo calculated by multiplying the degree of skin depigmentation of the face

Time frame
Up to Day 1
4

Vitiligo Quality of Life (QOL), assessed by Vitiligo Quality of Life Score (VitiQoL) Vitiligo Only

VitiQoL is a 16-item instrument assessing impact of vitiligo on QoL. 15 items are scored on a 7-point Likert scale, ranging from "not at all" to "all the time". An additional item (not contributing to total score) assesses current severity of condition on a 7-point scale ranging from "no skin involvement" to "most severe case"

Time frame
Up to Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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