Safety and Efficacy study of Moisturizer.
- Registration Number
- CTRI/2020/05/025465
- Lead Sponsor
- Wipro Manufacturing Services Sdn Bhd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method