None listed
Conditions
Interventions
Intervention1: HBHB-122001 Pre- term Baby Hair and Body wash: The product will be applied topically during routine bathing 2-3 times per week for a period of 14 days.
Control Intervention1: Nil: Nil
Sponsors
Himalaya Wellness Company (HWC)
Eligibility
Inclusion criteria
Inclusion criteria: 1.Infants born in gestational age of 36 to 42 completed weeks 2.Study Protocol Specified Age Group: Infants whose gestational age plus chronological age falls within 36 to 42 weeks at the time of enrolment 3.Preterm born infants with a birth weight of greater than equal to 1500g will be eligible for study participation 4.Preterm born infants who no longer require Neonatal Intensive Care Unit care and are clinically stable at the time of screening 5.Preterm born infants of either gender male or female will be eligible for participation in the study 6.Preterm born infants whose parent or legal guardians are willing and able to comply with study procedures and visit schedules 7.Preterm born infants whose parent or legal guardian provide written informed consent prior to participation in the study 8.Preterm born infants with intact, clinically assessable skin suitable for study evaluations and product application, as determined by the investigator
Exclusion criteria
Exclusion criteria: 1.Preterm born infants whose combined gestational age and chronological age falls outside 36 to 42 weeks at the time of enrolment. 2.Preterm born infants with very low birth weight of less than 1500g. 3.Preterm born infants with known congenital anomalies or clinically significant systemic illnesses that may interfere with study assessments, as judged by the investigator. 4.Preterm born infants with active skin infections, severe dermatitis, or any dermatological condition at the intended sites of application that may confound study outcomes. 5.Preterm born infants with known or suspected hypersensitivity or allergy to any ingredient of the test product. 6.Preterm born infants receiving concurrent topical medications, medicated skin products, or emollients on the assessment sites volar arm that could interfere with study evaluations. 7.Preterm born infants should not participate in any other clinical study during their participation in the current study. 8.Any condition which, in the opinion of the investigator, may compromise the safety of the preterm born infants or the integrity of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of skin strengthening barrier assessed by changes in transepidermal water loss (TEWL) measured using a Tewameter on the volar forearm Preservation of acid mantle skin pH level assessed using Skin pH meter on volar forearm Evaluation of Mildness, Gentleness, Irritation, Flaking, using Investigator assessment scale Evaluation of Erythema, Dryness, breakdown/excoriation using Neonatal Skin Condition Score (NSCS) scale Improvement in overall skin outcomes of participants evaluated through questionnaire as reported by parents/guardians.Timepoint: Baseline (Pre-wash) (0 min), 30 min post- wash and Day 14(+1 day) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment, evaluated by monitoring and recording the incidence of adverse events throughout the study duration.Timepoint: Baseline (Pre-wash) (0 min),30 min post- wash and Day 14 plus 1 day | — |
Countries
India
Contacts
Public ContactMs Meena Dalal
Himalaya Wellness Company (HWC)
Outcome results
None listed