None listed
Conditions
Interventions
Intervention1: Baby Wash and Shampoo: External Use Wet baby hair and body apply pea sized amount of the Baby Body wash and Shampoo generously gently working up a lather and rinse well
Use once daily
Sponsors
Azafran Innovacion ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (inclusive of both genders) at the time of consent 2 Babies general in good health as determined from a recent medical history 3 Babies mother or legal representative preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up 4 Babies mother or legal representative preferably mother willing to abide by and comply with the study protocol 5 Babies should not participate in any other clinical study during participation in the current study
Exclusion criteria
Exclusion criteria: 1 Subjectââ?¬•s mother or legal caretaker not willing to stop the use of other baby body milk or lotion or cream or any other baby face or body moisturizing product during the study period 2 Chronic illness which may influence the cutaneous state 3 Subject on any systemic medication 4 Subject with birth defects and anomalies 5 Subject participating in a similar clinical study currently or during the previous 30 days 6 Any subject in the Investigators opinion not considered suitable for enrollment 7 A known history or present condition of allergic response to any other concern that may require medical attention 8 Babies with medical history (past present) of significant dermatological diseases or conditions such as atopy psoriasis vitiligo or other conditions known to alter skin appearance or physiologic response (eg.porphyria) chronic urticaria or sunburn rashes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babiesââ?¬â?¢ skin using pediatrician assessment 2 To determine the baby experienced no tear, provide quick clean, smooth and gentle effect on baby skin and hair and smooth and shiny hair by subjective self-assessment questionnaire from babiesââ?¬â?¢ mother/ legal caretaker Timepoint: 1. Day 01 Before application, Day 15 after application 2. Day 15 after application. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 The effect of test product will be evaluated on improvement in the skin hydration using CorneometerÃ?® CM 825 or Moisture Meter SCTimepoint: 1 Day 01 Before application, Day 15 after application. | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed