Health Condition 1: L208- Other atopic dermatitis
Conditions
Interventions
Intervention1: Body Lotion: Subjects will be instructed to apply pea�sized amount of test product twice a day for each eczema site on their body to moisturize the test skin site
Intervention2: Bo
Sponsors
Wipro Manufacturing Services Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years (both inclusive) old healthy, non-pregnant, and non-lactating female at the time of consent. 2. Females who have childbearing potential should have a negative urine pregnancy test at the time of the screening visit. 3. Mild to Moderate Eczema determined by Eczema Area and Severity Index (EASI) score on screening visit. [Subjects with moderate erythema (Redness: score 2) and mild scratch mark (Scratching: score 1) will be enrolled in the study]. 4. Subjects with at least two active lesions on feet/face/hands or any part of the body. 5. Subjects have only a few or no pigmentation on the selected test site. 6. The subjectââ?¬•s in general good health as determined by Investigator based on medical history. 7. Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before scheduled study visits. 8. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits. 9. Subjects must be able to understand and provide written informed consent to participate in the study. 10. Subjects should be willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Selection of unaffected and affected test sites by the dermatologist using instrument evaluations. 2. Calculation of eczema area by dermatologist using Eczema Area and Severity Index (EASI). Timepoint: 1. On Day 01 before application and on Day 14 and Day 28 after product usage 2. On Day 01 before application and Day 14 and Day 28 after product usage | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. cutaneous tolerance/ local irritation i.e. Erythema, Oedema, Dryness, Flaking, Scaling, Itching, Peeling, Pigmentation for body wash and body lotion 2. Global Assessment Scale (IGA) for body wash and body lotion 3. itchiness of skin using Itch NRS scale for body lotion 4. subjective self-assessment i.e. perceived symptoms of irritation such as Burning, Itching, and Stinging for body wash and body lotion 5. subjective perception about product for body wash and body lotion Timepoint: 1. On Day 01, Day 14 and Day 28 2. On Day 01, Day 14 and Day 28 3. Day 01 i.e. Baseline, 0 sec before application, to 10 sec, 20 sec, 30 sec, 40 sec, 50 sec, 60 sec, 2 min, 5 min, 10 min and 15 min after application on Day 01. 4. On Day 01, Day 14 and Day 28 5. On Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed