A Real-world Prospective Cohort Study of Patients With Moderate to Severe Acne Vulgaris Treated With Sarecycline (Seysara®) In Community Practice Settings in the U.S
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are administered sarecycline (Seysara®) in real-world community practice settings in the United States (U.S). Investigator's Global Assessment (IGA) of AV and safety measures associated with use of sarecycline (Seysara®) will be assessed over the study observation period of 12 weeks. Clinicians will prescribe sarecycline (Seyara®) as per their own clinical judgment and standard practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Male or female, aged 9 years and above
- •Has facial non-nodular AV with IGA score of moderate or severe
- •Considered as a potential candidate for sarecycline (Seysara®) treatment, per clinician judgment
- •Caregiver Inclusion Criteria:
- •Primary caregiver of the study-eligible patient
- •Male or female, aged 18 years and above
排除标准
- •Patients with any known resistance to other tetracyclines
- •Patients with any dermatological or physical condition of the face that could interfere with the AV clinical evaluations.
- •Patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis.
- •Unable to comply with the requirements of the study or patients who in the opinion of the Site Investigator should not participate in the study
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Sarecycline
Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment.
干预措施: Sarecycline (Drug)
结局指标
主要结局
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12
时间窗: Baseline, Week 12
Patient related outcome (PROs) assessment performed using ASIS Questionnaire, a 17-item questionnaire that asks participants about the signs, impact (emotional and social) of AV, responses were reported as two scales: Signs (9 items), and Impact (8 items). Impact domain had two sub-scales, pertinent to Emotional (6 items) and Social impact (2 items). All items are scored on a 5-point scale: 0 (best) to 4 (worst). A domain score is determined by the average of scores in each scale within the domain. The total score is the average of all 17 items. Higher scores on the ASIS Sign domain, comprised of all items that assess symptoms (items 1-9), indicate the presence of more severe symptoms, whereas higher scores on the ASIS Impact domain, comprised of all the items that assess impacts (items 10-17), indicate a greater negative impact of acne.
次要结局
- Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12(At Week 12)