A clinical study to evaluate Dermatitis Lotion for treatment of Atopic Dermatitis in Childre
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2020/12/029971
- Lead Sponsor
- Amitojas Wellness Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-Oriented Eczema Measure (POEM) score documented in the CRF baseline, day 30, day 60 and day 90Timepoint: baseline, day 30, day 60 and day 90
- Secondary Outcome Measures
Name Time Method Skin Tone, Skin Texture and Moisturisation of Atopic Dermatitis affected areas documented in the CRF baseline, day 30, day 60 and day 90Timepoint: baseline, day 30, day 60 and day 90