None listed
Conditions
Interventions
Intervention1: Diaper Rash Ointment: apply 1.5 g to 2.5 g of test product (as per requirement) directly on the babyâ??s affected rash site, around buttocks and thighs area also between the buttocks an
Sponsors
Zydus Wellness Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Baby in the age group of 0 including newborn babies Day 1 to 36 months inclusive of both genders at the time of consent. 2. Baby generally in good health as determined from recent medical history. 3. Baby who wears diapers at least 12 hours per day. 4. Babies with the presence of Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator 5. Baby mother or legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up. 6. Baby mother or legal representative, willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams, or powders during the trial. 7. Baby mother or legal representative willing to refrain from changing any other products whose use may have an effect on their childs skin condition during the trial example laundry detergents, fabric softeners, and products used to bath the child. 8. Baby mother or legal representative, preferably mother willing to abide by and comply with the study protocol. 9. Babies should not participate in any other clinical study during participation in the current study.
Exclusion criteria
Exclusion criteria: 1. Baby mother or legal caretaker not willing to stop the use of other baby body milk or lotion or cream or any other baby face or body moisturizing product during the study period. 2. Chronic illness which may influence the cutaneous state. 3. Babies currently being toilet trained. 4. Baby participating in a similar clinical study, currently or during the previous 30 days. 5. Any Baby, in the Investigators opinion not considered suitable for enrollment. 6. A known history or present condition of allergic response to any other concern that may require medical attention. 7. Babies with medical history past or present of significant dermatological diseases or conditions, such as atopy, psoriasis, eczema, vitiligo or other conditions known to alter skin appearance or physiologic response example porphyria, chronic urticaria, or sunburn, rashes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess overall severity scoring scale change from baseline Day 01 before application to after test product application. 2. To assess baby diaper rash skin in terms of mildness, gentleness, and non-irritability, erythema or redness, dryness, itching, rashes, oedema, pruritus, urticaria of babiesâ?? skin by using pediatrician assessment by the consulting pediatrician 3. To assess subjective self-assessment questionnaire after test product use.Timepoint: 1. at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14 by Pediatrician. 2. Day 01 before application to after test product application at Time 30 min, 1 hour, 2 hours, 4 hours, 6 hour, 12 hours, 24 hours, Day 07 and Day 14 3. Time 30 min, 1 hour, 2 hours, 4 hours, 8 hour, 12 hours, 24 hours, Day 07 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess effect of test product on baby diaper rash skin for erythema using Mexameter® MX 18 2. To assess effect of test product on baby diaper rash skin for barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or Vapometer 3. To evaluate the pain relief ability of test product on baby diaper rash skin by VAS scoring scale 4. To evaluate the effect of test product on adult subjectâ??s/babyâ??s affected skin pH using Skin pH meterTimepoint: 1. Day 01 before application to after test product application at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14. 2. Day 01 before application to after test product application at Time 6 hour, 12 hours, 24 hours, Day 07 and Day 14. 3. Day 01 before application to after test product application at 12 hours, 24 hours, Day 07 and Day 14. 4. Day 01 before application to Day 14 | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed