Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 92
- 试验地点
- 14
- 主要终点
- EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
研究概览
简要总结
The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age of 18 years or older
- •A clinical diagnosis of facial rosacea
- •A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug application
- •A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application
排除标准
- •More than 5 facial inflammatory lesions (papules or pustules) of rosacea
- •Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator
- •Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure)
- •Female who is pregnant or lactating
研究组 & 干预措施
Brimonidine tartrate 0.5% gel
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
干预措施: Brimonidine tartrate was applied cutaneously once daily for 8 days. (Drug)
Vehicle
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
干预措施: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. (Drug)
结局指标
主要结局
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
时间窗: Day 8
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
Percentage of Participants With Facial Redness Questionnaire at Day 8
时间窗: Day 8
Percentage of participants for each category of facial redness questionnaire on Day 8 was reported. Facial redness questionnaire included 12 questions/categories 1. Satisfied with appearance, 2. Appearance acceptable, 3. Appearance concerned, 4. Embarrassed with facial redness, 5. Self-conscious, 6. Frequency control last 24 hours, 7. Frustrated, 8. Cover up or camouflage, 9. Pay attention to the known triggers, 10. Avoid the known triggers, 11. Interfering with social life, 12. Interfering with work life.
Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment
时间窗: Day 8
Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
时间窗: Baseline, Day 8
DLQI was a compact health-related quality of life index that has 10 questions and depends on the participants self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. \[Grade 0-1\]: No effect at all on participant's life, \[Grade 2-5\]: Small effect at all on participant's life, \[Grade 6-10\]: Moderate effect at all on participant's life, \[Grade 11-20\]: Very large effect at all on participant's life, \[Grade 21-30\]: Extremely large effect at all on participant's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater.
Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8
时间窗: Day 8
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
次要结局
- Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)(Day 8)
- Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment(Day 8)
- Change From Baseline in Facial Inflammatory Lesion Counts at Day 8(Day 8)
- Number of Participants Reported Adverse Events(From start of study drug administration up to Day 8)