Safety In-Use Study to Assess the Cutaneous Tolerance of Test Product i.e. Baby Cream in Healthy Babies of 0 to 36 Months of Age

Azafran Innovacion Limited0 个研究点目标入组 38 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
•4)Babies mother/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.
•Additional Criteria for babies with atopic dermatitis:
•6)Babies with mild to moderate atopic dermatitis assessed using TIS score and parental questionnaire as per dermatologist examination will be included in the study.

•1)Subjectâ??s mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / cream or any other baby face/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 (e.g. porphyria) chronic urticaria, or sunburn, rashes.

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