A clinical study to evaluate the effect of a Diaper Rash Cream in Healthy Babies of 6 to 36 Months of Age.
- Registration Number
- CTRI/2024/05/066744
- Lead Sponsor
- prising Science Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1) Babies who are generally in good health as determined from a recent medical history and the pediatrician.
2) Babies having an Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator.
3) Babies who wear diapers for at least 12 hours per day.
4) Babies delivered after complete gestation (more than 38 weeks).
1) Babies mother/legal caretaker not willing to stop the use of other baby products other than the provided test product on the affected area during the study period.
2) Babies with chronic illness / systemic illness which may influence the cutaneous state.
3) Babies on any systemic medication / undergoing treatment for skin disorders.
4) Babies with diarrhea/ bowel incontinence.
5) Babies who are currently being toilet trained.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of severity of rashes by a Pediatrician using overall severity scoring scaleTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (+ 2 hours) post application), Day 07 and Day 14
- Secondary Outcome Measures
Name Time Method Assessment of erythema of the affected area using Mexameter® MX 18Timepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14;Assessment of product’s mildness and gentleness on baby’s skin by a Pediatrician using 5-point grading scaleTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application, Day 07, Day 14;Assessment of skin barrier function using TEWAmeter® TM300/VapometerTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14;Product Perception by taking feedbackTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14