None listed
Conditions
Interventions
Intervention1: Baby soap: Wet baby�s face and body
apply the Baby Soap generously, gently working up a lather and rinse well.
Use once daily for 14 days.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Azafran Innovacion Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Babies in the age group of 0 (including new born full term babies of 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. 3) Babies general in good health as determined from a recent medical history 4) Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up. 5) Babies 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) Babiesââ?¬• mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / massage oil or any other baby face/body moisturizing product during the study period. 2) Chronic illness which may influence the cutaneous state as per Investigator. 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 safety of the test product will be evaluated the on skin in terms of mildness, gentleness and non-irritability of babiesââ?¬â?¢ skin by pediatrician assessment change from baseline. 2. To determine the baby experienced no tear, provide quick clean, smooth and gentle effect on baby skin and hair by subjective assessment questionnaire from babiesââ?¬â?¢ mother/ legal caretaker after test product application on Day 15.Timepoint: 1. Day 01 before application to Day 15 after application. 2. Day 15 after test product application. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect of test product will be evaluated on improvement in the skin hydration using CorneometerÃ?® CM 825 or MoistureMeter SC change from baseline.Timepoint: 1. Day 01 before application to Day 15 after application. | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed