Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Massage Oil in Healthy Babies of 0 to 36 Months of Age

Azafran Innovacion ltd0 sites38 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 25, 2020

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Azafran Innovacion ltd

•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.