None listed
Conditions
Interventions
Intervention1: Biomimic Aqua Face Cream: Route of administration: Topical
Application site: Face
Mode of usage: Apply a thin, even layer of the cream to the baby s clean and dry face and gently spread
Sponsors
R For Rabbit Baby Products Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Gender: A total of 16 Male and Female babies 2.Age: 0 36 months (both inclusive). 3.Participant in good general health as determined by the Investigator on the basis of medical history. 4.Parent(s)/legally acceptable representative(s) willing to comply with study procedures and provide written informed conserequirements. 5.Not to use any other marketed product on application site during the study period. 6.Participants presenting with one or more signs and symptoms of diaper rash (e.g., redness, itching, or burning) that do no treatment will be included. 7.Participants/ Babies who uses diaper regularly.
Exclusion criteria
Exclusion criteria: 1.Participant has any known allergy to test product ingredient. 2.Participant has had any chronic disease or illness in the past three months or any clinically significant on-going chronic medidisease, Congestive heart failure, Hepatitis, Hypotensive episodes, etc. 3.Participant has participation in any similar consumer study within the past 90 days. 4.Participant is currently using any topical medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Test Product 1 1. To evaluate the safety of test product by assessing the change in local skin intolerance (skin dryness, irritation, redness, scaling) by Paediatrician and/or Paediatrician Trained Evaluator. 2. To evaluate the safety of the test product by assessing change in skin pH using pH meter. 3. To evaluate the effect of the test product by assessing change in skin hydration level using Corneometer CM 825. for all test products 4. To evaluate the safety of the test products in terms of Product Perception Questionnaire by Participant s mother s Caregiver feedback using a 5-point Likert scale for test product 2 and 3 5. To evaluate the safety of test products by assessing the change in local skin intolerance (skin dryness, irritation, redness, scaling) by Paediatrician and Paediatrician Trained Evaluator and reduction in diaper rashes (For Diaper rash cream)Timepoint: For Test Product 1 1. To evaluate the safety of test product by assessing the change in local skin intolerance (skin dryness, irritation, redness, scaling) by Paediatrician and/or Paediatrician Trained Evaluator. 2. from baseline before test product usage on Day 01 and after usage of test products on Day 15 ( 2 Days). 3.from baseline before test product usage on Day 01 and after usage of test products on Day 02 and Day 15. 4. at Day 15 after product use 5. from baseline before test products usage on Day 01 and after usage of test products on Day 15 ( 2 Days). | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed