CTRI/2020/12/029971
Not yet recruiting
Phase 4
Evaluation of efficacy and safety of Dermatitis Lotion in the treatment of Atopic Dermatitis in Children: A prospective, single center, interventional study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Sponsor
- Amitojas Wellness Private Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female children aged \>\= 6 months to \<\=12 years.
- •2\. Subject diagnosed with Atopic Dermatitis as per the medical judgement of the study investigator.
- •3\. Subject with mild to severe eczema as determined by the Patient\-Oriented Eczema Measure (POEM) score.
- •4\. Children willing to provide informed assent if applicable.
- •5\. Childâ??s parent/guardian/legally acceptable representative willing to provide informed written consent.
Exclusion Criteria
- •1\. Children with significant medical/surgical condition which requires long\-term treatment.
- •2\. Children with genetic diseases, congenital diseases and mentally challenged.
- •3\. Children who are currently being treated with other atopic dermatitis drugs.
- •4\. Subject has clinically infected atopic dermatitis at the time of screening.
- •5\. Allergy or sensitivity to any of the ingredients in the study treatment.
- •6\. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallely.
- •7\. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
Outcomes
Primary Outcomes
Not specified
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