Efficacy and safety of Atogla Resyl® in comparison to placebo to maintain the remission phase of atopic dermatitis (AD) in infants and children with mild tomoderate AD.

Not Applicable

• Conditions: Health Condition 1: L20- Atopic dermatitis

• Registration Number: CTRI/2021/01/030337
• Lead Sponsor: Curatio Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified