Evaluation of Therapeutic Effects of ZAX.1400.P03 a Herbal Compound on Clinical Signs of Skin in Psoriasis Patients
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
研究概览
简要总结
The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:
• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.
Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of the disease by a doctor
- •Age range between 18 and 60 years
- •Both sexes (male and female)
- •Having written informed consent to participate in the study
- •Lack of allergy to food and health products
- •Only local tissue involvement and no need to take oral medications
- •Absence of underlying diseases and immune deficiency
- •Absence of pregnancy and breastfeeding
- •Absence of blisters and infection caused by the disease
排除标准
- •Non-consent of the doctor directly responsible for the patient
- •Incidence of drug product allergy
- •Occurrence of symptoms of skin, digestive, liver or kidney diseases
- •Patient's lack of consent to continue for any reason
研究组 & 干预措施
Topical ZAX.1400.P03
ZAX.1400.P03, applied topically twice daily for 3 weeks after enrolment
干预措施: ZAX.1400.P03 (Dietary Supplement)
Placebo
Placebo, applied topically twice daily for 3 weeks after enrolment
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
时间窗: Baseline and Weeks 1, 2, 3, 4, 5, and 6
DLQI score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42
次要结局
- Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42(Baseline and Weeks 1, 2, 3, 4, 5, and 6)
研究者
Akbar Farjadfar
Principle-Investigator
Fasa University of Medical Sciences