A Prospective Interventional Randomized Parallel Double blind Comparative Clinical Study to evaluate the Efficacy and Safety of MEZO cream 0.1 % (Mometasone Furoate USP 0.1%) with ELOCON Cream 0.1%(Mometasone Furoate 0.1%) in the treatment of plaque psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the improvement in psoriatic sign and symptoms using a scale
研究概览
简要总结
“A Prospective, Interventional, Randomized, Parallel, Double blind, Comparative, Clinical Study to evaluate the Efficacy & Safety of MEZO cream 0.1% (Mometasone Furoate USP 0.1%) with ELOCON® Cream, 0.1% (Mometasone Furoate 0.1%) in the treatment of plaque psoriasis.’’
| Total of 60 subjects |
Test: - 30 subjects [MEZO cream 0.1% (Mometasone Furoate USP 0.1%)]
Reference: - 30 subjects [ELOCON®cream 0.1% (Mometasone Furoate 0.1%)]
-Male and Female subjects having age 18 and above will be enrolled in the study.
| -Psoriasis patients with mild to moderate as classified by investigator based on body surface area. |
[Mild to moderate psoriasis means that the red, scaly patches ("plaques") cover less than 10% of your body]
The study duration is 72 days (Around 10 weeks (6 weeks treatment plus follow up after 1 month))
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults of both sexes Age 18 or older with good mental health Psoriasis patients with mild to moderate as classified by investigator based on body surface area Mild to moderate psoriasis means that the red scaly patches plaques cover less than 10 percent of your body Subject who in the opinion of the investigator are free of any medical condition s that may interfere with study participation or affect study measures Willing to provide written informed consent for participation in the study and adhere to the protocol requirements Patients who agreed to return for follow-up visits.
排除标准
- •Patients who are not willing to give written informed consent Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal Other types of skin damage that was not psoriasis Pregnant and nursing women Patients using oral anticoagulants Any finding of clinical observation that is interpreted by the investigator as a risk to the patients participation in the study 7.Severely immune compromised patients Use of any investigational drug currently or within 30 days prior to study entry Subjects on any prescription medication that might interfere with study outcomes History of alcohol or drug abuse Patients having Impetigo cellulitis lymphangitis.
结局指标
主要结局
To assess the improvement in psoriatic sign and symptoms using a scale
时间窗: baseline EOT
Parameters will be evaluated for erythema plaque size Scaling itching thickness of the lesion
时间窗: baseline EOT
次要结局
- Self Assessment of General Health(Tolerance)