None listed
Conditions
Interventions
Intervention1: Baby Diaper: Test baby diaper to be used on the baby�s skin for consecutive 14 days (2-weeks) by each subject (baby)
Control Intervention1: Not Applicable due to single arm study
Sponsors
R for Rabbit Baby Products Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effect of the test diaper in terms of mildness, gentleness, non-irritability, skin erythema/redness, dryness, rashes, itching by the pediatrician assessment scoring. 2. To assess the effect of the test diaper in terms of local intolerance i.e. skin erythema/redness, dryness, rashes, itching by the dermatologist or dermatologist trained scorerââ?¬â?¢s assessment scoring. 3. To assess babyââ?¬â?¢s experienced on following: - Provides soft and tender care with less friction of the diaper - No diaper rash develop - Less frequent change of diapers / overnight use, - Undisturbed/restful sleep for the baby - Less crying, less cranky after waking up - No occurrence of leakage of urine or feces; - Comfort of diaper application and removal, - Overall satisfaction of the product Using ââ?¬Ë?Subjective Product Perception Assessmentââ?¬â?¢ for baby after test product use on Day 15 (Ã?±2 days).Timepoint: 1. To assess the effect of the test diaper in terms of mildness, gentleness, non-irritability, skin erythema/redness, dryness, rashes, itching by the pediatrician assessment scoring. 2. To assess the effect of the test diaper in terms of local intolerance i.e. skin erythema/redness, dryness, rashes, itching by the dermatologist or dermatologist trained scorerââ?¬â?¢s assessment scoring. 3. To assess babyââ?¬â?¢s experienced on following: - Provides soft and tender care with less friction of the diaper - No diaper rash develop - Less frequent change of diapers / overnight use, - Undisturbed/restful sleep for the baby - Less crying, less cranky after waking up - No occurrence of leakage of urine or feces; - Comfort of diaper application and removal, - Overall satisfaction of the product Using ââ?¬Ë?Subjective Product Perception Assessmentââ?¬â?¢ for baby after test product use on Day 15 (Ã?±2 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of babiesââ?¬â?¢ skin will be assessed by local intolerance evaluation [Erythema, Dryness, Oedema, Urticaria, Pruritus, Allergic Reaction and any other if any] of test product on Day 15 and incidence of adverse event: Either self-reported by mother/legal guardian of babies or assessed by Pediatrician/Dermatologist.Timepoint: Day 01 and Day 15 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt. Limited
Outcome results
None listed