None listed
Conditions
Interventions
Intervention1: HBBL-122003 Baby Lotion: Parents/guardians will apply a sufficient quantity of HBBL-122003 baby lotion over the infants body, including hands and legs, once daily after bathing for 21 c
Sponsors
Himalaya Wellness Company HWC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants born in gestational age of 28 37 completed weeks. 2. Study Protocol-Specified Age Group-SPSAG: Infants whose gestational age plus chronological age falls within 36 42 weeks at the time of enrolment. 3. Preterm born infants with birth weight of Greater than equal to 1500 grams will be eligible for study participation. 4. Preterm born infants who no longer require Neonatal Intensive Care Unit (NICU) 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 parents/legal guardian are willing and able to comply with study procedures and visit schedules. 7. Preterm born infants whose parent/legal guardian(s) 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 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 a 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 that could interfere with study evaluations. 7.Preterm born infants should not participate in any other clinical study during 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 |
|---|---|
| 1. Improvement in skin barrier function (TEWL assessment). 2. Improvement in skin hydration (Corneometer assessment). 3. Maintenance/normalization of skin pH levels. 4. Improvement in skin condition (mildness, gentleness, flaking, hydration, softness, and smoothness) based on Investigator Assessment. 5. Improvement in neonatal skin health assessed using NSCS. 6. Improvement in overall skin-related outcomes based on Parent/Guardian feedback.Timepoint: Baseline (Day 1), 30 minutes post-application on Day 1, Day 7, Day 14, and Day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by incidence of adverse events throughout the study period.Timepoint: Baseline (Day 1), 30 minutes post-application on Day 1, Day 7, Day 14, and Day 21. | — |
Countries
India
Contacts
Public ContactDr Nimisha Sivanandan
Himalaya Wellness Company (HWC)
Outcome results
None listed