None listed
Conditions
Interventions
Intervention1: All Purpose Cream: Subject will be instructed to apply 1.5 g to 2.5 g (a coin size) of test product (as per requirement) twice a day (morning and evening) directly on the face, body and
Sponsors
Zydus Wellness Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 0 Months to 60 years old (both inclusive) at the time of consent/assent. 2. Gender: Male or females 3. Females who have child bearing potential should have negative urine pregnancy test at the time of screening visit. 4. Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects and subjectââ?¬•s Parent/legal guardian/caregiver. 5. APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days [Refer Appendix VII for APGAR scoring]. 6. Subjects [0 months to 17 years] with mild to moderate eczema determined by Three-Item Severity (TIS) score on screening visit will be enrolled into the study. 7. Subjects [18 to 60 years] with 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]. 8. Written informed consent from the Parent/legal guardian/caregiver and verbal/oral assent from children between 7 to 12 years of age in the presence of their parent/legal guardian/caregiver. 9. Written informed consent from the Parent/legal guardian/caregiver and written assent from children between 12 to 18 years of age. 10. Subjectââ?¬•s participating patent/legal guardian/caregiver must be able to provide government authorized legal proof of childââ?¬•s to participate in the study. 11. Subjects must agree to refrain themselves from shower/bath or generally wet their skin within 3 hours before a schedule study visits. 12. Subjects must use test product on your skin to reduce dryness, especially after a bath when their skin is still moist. 13. Subjects must agree to wear loose clothing to allow easy exposure to the entire body during study visits. 14. Subjects ensure and confirm that they will be refrained from changing any other products whose use may have an effect on their skin condition during the trial, i.e., laundry detergents, fabric softeners, and products used for bathing. 15. Subjects preferably willing to abide by and comply with the study protocol. 16. Adult subjects should not participate in any other clinical study during participation in the current study.
Exclusion criteria
Exclusion criteria: 1. Pregnant female subjects or females planning to get pregnant during study duration. 2. Subjects and subjectââ?¬•s participating parent/ legal guardian/caregiver not willing to stop the use of other body milk /lotion / cream or any other face/body moisturizing product during the study period. 3. Subjects with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product. 4. Subjects with Chronic illness which may influence the cutaneous state. 5. Subjects with any systemic illness that would impact on the subjectââ?¬•s safety or wellbeing and/or affect the response of the skin or the interpretation of the test results at screening. 6. Subjects participating in a similar clinical study, currently or during the previous 90 days. 7. Subjects in the Investigators opinion not considered suitable for enrollment. 8. Subjects with known history or present condition of allergic response to any other concern that may require medical attention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess effect of test product on adult subjectââ?¬â?¢s affected skin by using Eczema Area and Severity Index (EASI). 2. To assess effect of test product on babyââ?¬â?¢s affected skin by using Three-Item Severity (TIS). 3. To assess effect of test product on skin in terms of mildness, gentleness, non-irritability, skin erythema/ redness, dryness, itching, rashes, oedema, pruritus, urticaria 4. subjective self-assessment questionnaire Timepoint: 1. Day 01 before application to 12 (Ã?±2) hours, 24 (Ã?±2) hours, Day 07 (Ã?±2 Days) and Day 14 (Ã?±2 Days). 2. Day 01 before application to 12 (Ã?±2) hours, 24 (Ã?±2) hours, Day 07 (Ã?±2 Days) and Day 14 (Ã?±2 Days) 3. Day 01 before application to 12 (Ã?±2) hours, 24 (Ã?±2) hours, Day 07 (Ã?±2 Days) and Day 14 (Ã?±2 Days) 4. Time 30 min (Ã?±5 mins), 1 hour (Ã?±15 mins), 2 hours (Ã?±15 mins), 4 hours (Ã?±15 mins), 8 hours (Ã?±15 mins), 12 (Ã?±2) hours, 24 (Ã?±2) hours, Day 07 (Ã?±2 Days) and Day 14 (Ã?±2 Days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess effect of test product on adult subjectââ?¬â?¢s/babyââ?¬â?¢s affected skin for erythema using MexameterÃ?®MX 18 2. To evaluate the effect of test product on adult subjectââ?¬â?¢s/babyââ?¬â?¢s affected skin pH using Skin pH meter Timepoint: 1. Day 01 before application to 12 (Ã?±2) hours, 24 (Ã?±2) hours, Day 07 (Ã?±2 Days) and Day 14 (Ã?±2 Days) 2. Day 01 before application to Day 14 (Ã?±2 Days) | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed