Multi-Country, Cross-sectional Study to Characterize Real World Burden of Disease in Adolescent and Adult Patients With Alopecia Areata, Vitiligo or Hidradenitis Suppurativa (MEASURE AAVitHS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,795
- 试验地点
- 202
- 主要终点
- Alopecia Areata (AA) symptoms affecting quality of life and daily functioning, assessed by the Alopecia Areata Symptom Impact Scale (AASIS) AA only
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Participants with Hidradenitis Suppurativa
Participants with hidradenitis suppurativa will undergo a single-visit data collection per routine clinical practice
Participants with Vitiligo
Participants with vitiligo will undergo a single-visit data collection per routine clinical practice
Participants with Alopecia Areata
Participants with alopecia areata will undergo a single-visit data collection per routine clinical practice
结局指标
主要结局
Alopecia Areata (AA) symptoms affecting quality of life and daily functioning, assessed by the Alopecia Areata Symptom Impact Scale (AASIS) AA only
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点