An open label, phase II study To Evaluate The Safety And Efficacy of EczeroÂ® cream in subjects with Mild to Moderate Eczema.Protocol ID : IHS/PEL/01/14

Piramal Enterprises Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Adult males and females >=18 years and less than 75 years of age.
•2.Patients having chronic eczema (suffering from eczema from the past 1 year) with an EASI score in the range of 7-15. (Both inclusive).
•3.Patient not having any systemic immunosuppressive therapy(eg steroids)
•4.Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD).
•5.Stable, adequately treated medical conditions other than eczema (such as stable blood pressure, stable hypertension, hyperlipidemia & uncomplicated osteoarthritis).
•6.Subjects who are able and willing to give written informed consent.

•1.Patients having history of Medical conditions such as Diabetes mellitus, Thyroiditis, Rheumatoid arthritis, Multiple sclerosis, Uveitis, Glomerulonephritis, Helminthic, uncontrolled hypertension, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease.
•2.Patient having abnormal values above or below Â±20% of the normal value range as mentioned in the protocol.
•3.Females using oral contraceptives.
•4.History of any topical or herbal drug hyper sensitivity.
•5.History of alcoholism& drug abuse.
•6.Significant infection such as influenza, acute gastrointestinal symptoms e.g. nausea, vomiting, diarrhea, heartburn) at the time of screening and/or admission.
•7.Subjects who have used any investigational drug and /or participated in any clinical trial.
•8.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarial and NSAIDs.
•9.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug, medicated oils or Creams; medicated shampoos, hair colouring, perms, hair chemical treatments; continuously for one month, three months prior to screening visit.
•10.Target lesions associated with secondary infections.

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