A Multicenter, Randomized, Vehicle-controlled, Efficacy and Safety Study of CD2027 3µg/g Oily Spray Applied Twice Daily for 8 Weeks in Subjects With Plaque-type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 88
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Success Rate 1 (SR1) at Week 8
研究概览
简要总结
This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening
- •Participant presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4
排除标准
- •Other type of psoriasis (other than plaque)
- •Significant abnormal lab findings
- •Hypercalcemia
研究组 & 干预措施
Calcitriol Vehicle
干预措施: Calcitriol Vehicle (Drug)
Calcitriol 3 mcg/g Spray
干预措施: CD 2027 (Drug)
结局指标
主要结局
Percentage of Participants With Success Rate 1 (SR1) at Week 8
时间窗: Week 8
Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation
时间窗: Baseline, Week 8
Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation).
Percentage of Participants With Success Rate 2 (SR2) at Week 8
时间窗: Week 8
Success Rate 2 was defined as percentage of participants who achieved "clear" or "almost clear" on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Change From Baseline in Dermatologic Sum Score (DSS) at Week 8
时间窗: Baseline, Week 8
DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition.
次要结局
- Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium(Baseline, Week 8)
- Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure(Baseline, Week 8)
- Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine(Baseline, Week 8)
- Change From Baseline in Calcitriol Plasma Levels(Baseline, Week 8)
- Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin(Baseline, Week 8)
- Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score(up to Week 8)
- Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium(Baseline, Week 8)
- Number of Participants With Adverse Events (AEs)(up to Week 8)
- Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus(Baseline, Week 8)
- Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact(Baseline, Week 8)
- Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)(Baseline, Week 8)
- Change From Baseline in Vital Sign Parameter: Heart Rate(Baseline, Week 8)