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

Condition(s) studied

Study summary

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

Primary outcome measure(s)

• Alopecia Areata (AA) symptoms affecting quality of life and daily functioning, assessed by the Alopecia Areata Symptom Impact Scale (AASIS) AA only — Up to Day 1
  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
• Measuring scalp hair loss, assessed by the Severity of Alopecia Tool (SALT) score. AA only — Up to Day 1
  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
• Measuring facial skin depigmentation, assessed by the Facial Vitiligo Area Scoring Index (F-VASI) Vitiligo Only — Up to Day 1
  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
• Vitiligo Quality of Life (QOL), assessed by Vitiligo Quality of Life Score (VitiQoL) Vitiligo Only — Up to Day 1
  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"
• Hidradenitis Suppurativa (HS) Quality of Life (QOL), assessed by Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) HS only — Up to Day 1
  CDLQI is a10-question index measuring health-related quality of life (HRQoL) over the last 7 days for patients suffering from a skin disease. The DLQI is used in participants aged 16 and over and the CDLQI has been validated from the ages of 4 to 16 years. Each item scored on a 4-point Likert scale, where 0 = not at all/not relevant/question unanswered and 3 = very much. Maximum total score = 30 (highest impact on QoL).
• Measuring disease severity, assessed by the International Hidradenitis Suppurativa Severity Scoring System (IHS4) HS only — Up to Day 1
  The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.

Trial sites (116)

+ 76 more sites — see the full list on the official registry below.

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