A randomized, double blind, cross-over, placebo controlled,clinical study to evaluate the efficacy of Atogla ResylÂ® in comparison to placebo to maintain the remission phase of atopic dermatitis (AD) in infants and children with mild tomoderate AD.

Curatio Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Must have clinical diagnosis of mild to moderate AD at Screening visit, defined as
•SCORAD index score between 5 to 40
•2. Must have AD affecting > 5% total body surface area (TBSA) at Baseline
•3. History of AD for at least 3 months prior to Baseline
•4. Informed assent in accordance with the International Conference on Harmonization Good Clinical Practice Guideline and applicable regulations, before completing any study-related procedures
•5. Signature of the informed consent from a parent or a legal representative

•1. Patient with suspected or established primary immune deficiency.
•2 Patient with clinically infected AD at baseline.
•3 Patients who present with clinical conditions other than AD that may interfere with the evaluation
•4. Patients who Require (systemic therapy for the treatment of AD, Have any clinically significant skin disease other than AD, Have secondary infection of AD (bacterial, viral or fungal) within the skin area under study or
•open skin infections in any area at Baseline
•5. Chronic condition(s) which are either unstable or not adequately controlled
•6 Patients allergic to herbal products or any component of the study product
•7 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
•8 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

发起方

Curatio Healthcare Pvt Ltd