Safety in Use Study.
- Registration Number
- CTRI/2020/08/027020
- Lead Sponsor
- Azafran Innovacion ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babies� skin using pediatrician assessment <br/ ><br>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 babies� mother/ legal caretaker <br/ ><br>Timepoint: 1. Day 01 Before application, Day 15 after application <br/ ><br> <br/ ><br>2. Day 15 after application.
- Secondary Outcome Measures
Name Time Method 1 The effect of test product will be evaluated on improvement in the skin hydration using Corneometer�® CM 825 or Moisture Meter SCTimepoint: 1 Day 01 Before application, Day 15 after application.