TCTR20240330004尚未招募4 期
A Randomised, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy and Safety of Zoria Cream in the Treatment of Mild to Moderate Chronic Plaque Psoriasis
Pan Rajdhevee Group Public Co. Ltd.0 个研究点目标入组 24 人开始时间: 2024年3月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Healthy participant of the age of 20 years old or above, 2. Participant diagnosed with mild to moderate Chronic Plaque Psoriasis with less than 10% of body surface area involved, 3. Participant must give informed consent prior to study enrolment and all study procedures, 4. Participant must be able to comply with study procedures and be available for all study visits, 5. Participant must be in general good health based on medical history as determined by the investigator(s) at Screening.
排除标准
- •1. Participants not diagnosed with mild to moderate Chronic Plaque Psoriasis with less than 10 percent of body surface area involved, 2. Participants with signs of excoriation at the psoriatic lesion e.g., excoriated skin, scab, scratches, or broken skin associated with their plaques, 3. Participants diagnosed with other inflammatory diseases, 4. Participants who have previously used topical and systemic treatments for their psoriasis within 4 weeks prior to Screening and Enrolment (Day 1), 5. Participants who have previously used phototherapy, immunomodulatory therapy, or any other medicines known to influence psoriasis within 12 weeks prior to Screening and Enrolment (Day 1), 6. Participants with the presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participants interest to participate in the study, 7. Participants with a history of severe allergy (requiring hospital care), anaphylaxis, severe reaction to any drug, or any known or suspected allergies or sensitivities to any component of the Study Drug or Placebo, 8. Participants with a history of alcohol or drug abuse that, in the opinion of the PI(s), could affect the participant safety or compliance with study, 9. Participants with the presence of an acute illness, as determined by the PI(s), with or without fever (forehead temperature measured with validated device more than equal 37.5 degree Celsius) at Screening and Enrolment (Day 1), 10. Use of any other therapeutic or cosmetic products, devices or procedures that could interfere with the assessments of the treatment areas within 7 days prior to Screening and Enrolment (Day 1), unless approved by the PI(s), 11. Participants who are currently participating in any other interventional clinical trial or previously enrolled in an interventional clinical trial, which in the opinion of the PI(s) may interfere with the interpretation of the trial results, 12. Participants with a close affiliation with the PI(s), person working at the trial site(s) or an employee of the sponsor (e.g., a close relative).
研究者
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