None listed
Conditions
Interventions
Intervention1: Facial Moisturizer (BE/304/005/093): Subjects will be instructed to apply peaâ??sized amount of test product twice a day for each eczema site on their body to moisturize the test skin s
Sponsors
Wipro Manufacturing Services Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18to 65 years (both inclusive) old healthy, non-pregnant and non-lactating female at the time of consent. 2. Females who have child bearing potential should have negative urine pregnancy test at the time of 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 into the study]. 4. Subjects withat least two active lesion on feet/face/hands or any part of body. 5. Subject will undergo â??lactic acid stinging testâ?? at screening and subject with positive reaction to test will only be enrolled in the study. 6. Subjects have only few or no pigmentation on the selected test site. 7. Subjectâ??s in general good health as determined by Investigator based on medical history. 8. Subjects must agree to refrain from shower/bath or generally wet their skin within 3 hours before a schedule study visits. 9. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits. 10. Subjects must be able to understand and provide written informed consent to participate in the study. 11. Subjects should be willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with chronic or acute skin diseases, except atopic eczema on any part of the body. 2. Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product. 3. Subjects with any systemic illness that would impact on the subjectâ??s safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening. 4. Subjects who are receiving the following topical or systemic treatments. 5. Subjects with anti-inflammatory and/or anti-histaminesuse for 7 days previous to randomization and throughout the study. 6. Subjects with cough suppressants and/or topical or inhaled corticosteroids.Use for 7 days previous to randomization and throughout the study. 7. Subjects with use of retinoids and/or immunosuppressantâ??s during the previous 6 months. 8. Subjects have diabetes, acute cardiac and circulatory diseases, HIV, hepatitis. 9. Participation in a similar clinical study within the previous 90 days. 10. Any surgical treatment previous three months or planned during the study. 11. Any subject in the Principal investigators opinion not considered suitable for enrollment.
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 02, Day 07, Day 14 and Day 28 after application 2 On Day 01 before application and on Day 02, Day 07, Day 14 and Day 28 after product usage | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Dermatologist Visual Skin Assessment for erythema/redness and dryness. 2 To assess the effect of test product on Global Assessment Scale (IGA). 3 To assess the subjective self-assessment and subjective perception about product.Timepoint: 1 On Day 02, Day 07, Day 14 and Day 28 after application 2 On Day 02, Day 07, Day 14 and Day 28 after application 3 On Day 02, Day 07, Day 14 and Day 28 after application | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed