Safety in Use Study
- Registration Number
- CTRI/2020/09/027540
- 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 of Day 1) to 36 months (inclusive of both genders) at the time of consent.
2 APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days [Refer Appendix III for APGAR scoring].
3 Babies general in good health as determined from a recent medical history
4 Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
5 Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
6 Babies should not participate in any other clinical study during participation in the current study.
1 Babiesâ?? mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / massage oil or any other baby face/body moisturizing product during the study period.
2 Chronic illness which may influence the cutaneous state.
3 Babies on any systemic medication.
4 Babies participating in a similar clinical study, currently or during the previous 30 days.
5 Any baby, in the Investigators opinion not considered suitable for enrollment.
6 A known history or present condition of allergic response to any other concern that may require medical attention.
7 Babies with medical history (past | present) of significant dermatological diseases or conditions, such as atopy, eczema, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. 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 on skin in terms of mildness, gentleness and non-irritability of babiesâ?? skin by pediatrician assessment. <br/ ><br>2.The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 and MoistureMeterSCTimepoint: 1.Day 01 before application to Day 15 after application. <br/ ><br>2.Day 01 before application to Day 15 after application.
- Secondary Outcome Measures
Name Time Method Baby experienced no oily feel, provide quick spreadability, fragrance and smooth and gentle effect on baby skin by subjective assessment questionnaireTimepoint: Day 15 after test product application.