A Multi-centre, Double-blind, Double-dummy, Randomized, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 466
- 主要终点
- Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
研究概览
简要总结
Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
- •Subjects who require and agree to the concomitant use of a topical steroid preparation.
- •Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
- •Written informed consent signed and dated by subject/legal guardian
- •Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.
排除标准
- •Subjects with a known hypersensitivity to cetirizine or levocetirizine
- •Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- •Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol
研究组 & 干预措施
Levocetirizine
Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
干预措施: Levocetirizine (Drug)
Levocetirizine
Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
干预措施: Placebo-Cetirizine (Drug)
Levocetirizine
Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
干预措施: Standard topical steroid (1% hydrocortisone) ointment (Drug)
Cetirizine
Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
干预措施: Cetirizine (Drug)
Cetirizine
Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
干预措施: Placebo-Levocetirizine (Drug)
Cetirizine
Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
干预措施: Standard topical steroid (1% hydrocortisone) ointment (Drug)
结局指标
主要结局
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
时间窗: Day 7 and 14
A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.
次要结局
- Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period(Baseline and at endpoint during the 14 day treatment period)
- Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period(At endpoint during the 14 day treatment period)
- Global Improvement at Endpoint During the 14 Day Treatment Period(At endpoint during the 14 day treatment period)