An open label, single arm, clinical study to evaluate the safety and efficacy of HBBM-091723 in babies of 0 to 36 months of Age

The Himalaya Drug Company0 个研究点目标入组 40 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 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 generally with atopic dermatitis as per dermatologist examination.

•1)Babiesâ?? mother/ legal representative not willing to stop the use of other body lotion for their baby during the study period.
•2)Babies on any systemic medication.
•3)Babies with birth defects and anomalies.
•4)Babies participating in a similar clinical study, currently or during the previous 90 days.
•5)Any Babies in the investigators opinion not considered suitable for enrollment.
•6)Babies with medical history (past and 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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