An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Efficacy of Test Product i.e. Baby Diaper in 0 to 36 Months of Age Healthy and Babies with Atopic Dermatitis

R for Rabbit Baby Products Pvt Ltd0 sites32 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 12, 2021

Last Updated

3 years ago

Study Type

Interventional

Sponsor

R for Rabbit Baby Products Pvt Ltd

•1\.Babies in the age group of 0 to 36 months (inclusive of both genders).
•2\.APGAR score \>7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0\-7 days.
•3\.Babies in general good health as determined from a recent medical history and the pediatrician.
•4\. Babies mother/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent and agree to come for regular follow up.
•Only for Babies with Atopic Dermatitis
•5\. Babies with Atopic dermatitis having signs and symptoms as listed below but not limited to this
•\-Dry, scaly skin, itching, redness, swelling, thickened skin
•\-Small, raised bumps that may become crusty and leak fluid if scratched, rough bumps on the face, upper arms, and thighs.
•\-Darkened skin of eyelids or around the eyes.
•\-Skin changes around the mouth, eyes, or ears.

•1\.Babies with a known history or present condition of allergic response to any other Diapers, toiletries or its components or ingredients as in the test product.
•2\. Babies requiring incubators/ventilators or C\-PAP.
•3\. Babies having history or present condition of diaper rashes or any allergies in the diaper area.
•4\. Babies having history or present condition of diarrhea/ bowel incontinence
•5\. Babies having history or present condition of any pre\-existing systemic disease necessitating long term medications and other dermatological problems.
•6\. Babies who have participated in a similar clinical investigation in the past four weeks.