A Phase III, Multicentre, Randomized, Observer Blind, Parallel Group, Three Arms, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Topically Applied Calcipotriol/AKVANO 50 μg/g Cutaneous Solution Against Calcipotriol Ointment 50 Micrograms/g, Sandoz and Placebo in Patients With Mild to Moderate Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 14
- 主要终点
- Change in Psoriasis Area and Severity Index
研究概览
简要总结
This study is a Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis
详细描述
Total 278 patients with mild to moderate plaque psoriasis were randomized into the study. Study medications were applied twice daily for 8 weeks of study duration.
Patient's condition was assessed using of Physician's Global Assessment (PGA) and PASI Scale.
Primary objective of this study is to assess the therapeutic equivalence of Calcipotriol/AKVANO, 50 μg/g cutaneous solution with Calcipotriol Ointment 50 micrograms/g, Sandoz based on PASI score.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients (Non-pregnant) of plaque psoriasis aged 18 to 65 years having either Fitzpatrick skin type I-III or IV-VI.<br/>
- •Diagnosis of stable plaque psoriasis for 6 month by a dermatologist with lesions on arms, legs or trunk.
- •Mild to moderate psoriasis on Physician's global assessment (PGA),
- •Body Surface Area (BSA) involvement of 5-10% (both included) and PASI ≥
- •Patients must be willing to provide written informed consent and willing to comply with study requirements
排除标准
- •Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis
- •Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
- •Patient with any uncontrolled systemic disease
- •Patient with positive serology tests like HIV, HCV & HBsAg.
- •Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
- •Patient with spontaneously improving or rapidly deteriorating plaque psoriasis.
- •Use of systemic agents within four weeks prior to screening.
- •Use of biologic agents within four weeks prior to study entry.
- •Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry.
- •Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
- •Known sensitivity to any of the study treatments and/or study treatment's components.
- •Need for surgery or hospitalization during the study
- •Pregnant or nursing Female patient or planning a pregnancy
- •Concurrent involvement in any other clinical study within 30 days prior to entering the study
研究组 & 干预措施
Calcipotriol/AKVANO, 50 μg/g cutaneous solution
Spray formulation applied topically, twice daily, for the duration of 8 weeks.
干预措施: Calcipotriol/AKVANO, 50 μg/g cutaneous solution (Drug)
Calcipotriol Ointment 50 micrograms/g, Sandoz
Ointment applied topically, twice daily, for the duration of 8 weeks.
干预措施: Calcipotriol Ointment 50 micrograms/g (Drug)
Placebo
Spray formulation applied topically, twice daily, for the duration of 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Psoriasis Area and Severity Index
时间窗: Baseline to 8 weeks Post-randomization
Assessment of severity of psoriasis by comparing the change in Psoriasis Area and Severity Index between test and comparator (score ranging from 0 to 72, higher score means worsening of the disease)
次要结局
- More than 50 % reduction in PASI Score (PASI 50)(Baseline to 2, 4 and 8 weeks of treatment Post-randomization)
- More than 75 % reduction in PASI Score (PASI 75)(Baseline to 2, 4 and 8 weeks of treatment Post-randomization)
- Change in Irritation based on Visual Analogue scale (VAS)(Baseline to 2, 4 and 8 weeks of treatment Post-randomization)
- Change in itching based on Visual Analogue scale(Baseline to 2, 4 and 8 weeks of treatment Post-randomization)
- Incidence of Adverse Events and SAEs (Safety and Tolerability)(Till 8 weeks Post-randomization)
- Assessment of Physician's Global Assessment (PGA)(Baseline to 2, 4 and 8 weeks of treatment Post-randomization)