Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Dermatitis Lotion: The investigational product, Dermatitis Lotion is a nutraceutical product, formulated as a lotion which has Omega - 3 fatty acid oil (Seabuckthorn oil), Probiotic Lys
Sponsors
Amitojas Wellness Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female children aged >= 6 months to 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMr Kamal Kammili
Amitojas Wellness Private Limited
Outcome results
None listed