An Open Label, Single Arm, Multi-center, Prospective, Clinical Study to Evaluate Efficacy and Safety of WEL/PSO-01 in patients suffering from Chronic Plaque Psoriasis. - NI

Welex Laboratories Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months
•2. Subjects with plaque psoriasis having PASI score more than 10.
•3. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is more than 2 years postmenopausal.
•4. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

•1. Subjects who have received systemic treatment for Psoriasis such as Methotrexate or Cyclosporine therapy or any conventional systemic treatment for more than 4 weeks one month prior to screening in the study.
•2. Any laser dermatological procedure, 4 weeks prior to screening in this study.
•3. Known cases of Severe or Chronic hepatic or renal disease.
•4. Known case of any active malignancy.
•5. Subjects giving history of significant cardiovascular event less than 12 weeks prior to recruitment.
•6. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•7. Subjects participating currently or 1 month prior to recruitment in any other clinical study.
•8. Known hypersensitivity to any of the ingredients used in study drug.
•9. Pregnant and Lactating females.
•10. Any other condition due to which patients are deemed to be unsuitable by the investigatorâ??s opinion for reason(s) not specifically stated in the exclusion criteria

发起方

Welex Laboratories Pvt Ltd