Health Condition 1: L20- Atopic dermatitis
Conditions
Interventions
Intervention1: Atogla Resyl®: Topical application of Atogla Resyl® twice a day for 60 days
Control Intervention1: Placebo: Topical application of Placebo twice a day for 60 days
Sponsors
Curatio Healthcare Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in AD severityTimepoint: Day 0, Day 30, Day 60, Day 90, Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Bio markers and histopathologyTimepoint: Day 0, Day 60, Day 120,;Changes in Questionnaire based assessmentsTimepoint: Day 0, Day 30, Day 60, Day 90, Day 120;Changes in skin function parametersTimepoint: Day 0, Day 30, Day 60, Day 90, Day 120;Percentage change in AD relapse rateTimepoint: Day 0, Day 30, Day 60, Day 90, Day 120 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed