None listed
Conditions
Interventions
Intervention1: Baby Nourishing Cream: External Use â?? Rub the Baby Nourishing Cream gently in the morning after bath on babyâ??s face and body.
Control Intervention1: Not applicable: Not applicable
Sponsors
Azafran Innovacion ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (inclusive of both genders) at the time of consent. 2)APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days [Refer Appendix V for APGAR scoring]. 3)Babiesâ?? general in good health as determined from a recent medical history 4)Babiesâ?? mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up. 5)Babiesâ?? mother/legal representative, preferably mother willing to abide by and comply with the study protocol. 6)Babies should not participate in any other clinical study during participation in the current study
Exclusion criteria
Exclusion criteria: 1)Babiesâ?? mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / cream or any other baby face/body moisturizing product during the study period. 2)Chronic illness which may influence the cutaneous state. 3)Babies on any systemic medication. 4)Babies 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 | present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 or MoistureMeterSC change from baseline. 2.The effect of test product will be evaluated on skin barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or VapoMeter change from baselineTimepoint: At 0 hour before application to after application at 30 mins 1 hour 2 hours 4 hours 6 hours 8 hours 12 hours and 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective assessment questionnaire will be evaluated from babiesâ?? mother/ legal caretaker 2.The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babiesâ?? skin by pediatrician assessment change from baseline.Timepoint: 1.At 24 hours after test product application 2.At 0 hour before application and after application at 24 hour | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed