Clinical Study to evaluate the Efficacy and Safety of MEZO cream with ELOCON Cream in the treatment of plaque psoriasis
- Conditions
- Health Condition 1: L00- Staphylococcal scalded skin syndrome
- Registration Number
- CTRI/2019/11/021908
- Lead Sponsor
- AGIO PHARMACEUTICALS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the improvement in psoriatic sign and symptoms using a scale <br/ ><br>Parameters will be evaluated for erythema plaque size Scaling itching thickness of the lesionTimepoint: baseline EOT
- Secondary Outcome Measures
Name Time Method Self Assessment of General Health <br/ ><br>Tolerance <br/ ><br>To evaluate the quality of life <br/ ><br>Assessment of safety of the Investigational products <br/ ><br>Adverse event <br/ ><br>Physical examination <br/ ><br>Biomarker of systemic safety <br/ ><br> Hematological test <br/ ><br>Liver function test <br/ ><br>Renal function test Serum creatinine <br/ ><br>RBS <br/ ><br>Timepoint: baseline to EOT