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Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Conditions: Newborns
Interventions: Cosmetic Products
Countries: United Kingdom
The skin of a newborn has a sensitive skin barrier relative to an older child and an adult. Newborn's skin, for example, is extremely vulnerable to damage by environmental agents such as harsh detergents, some topical oils, and other irritant chemicals. Evolving perspectives on barrier dysfunction in newborn babies has led to the idea that there may be a window of opportunity in the first few months of a newborn's life to change the environmental agents that their skin is exposed to in order to maximize skin health. These environmental changes could involve the use of optimally formulated wash products and emollients, as well as the removal of all other irritant substances that could damage the skin barrier. Further research is required to identify skincare practices that are harmful and those that are positive, and to ultimately ascertain what the optimum skincare routine should be. An important skincare strategy is to identify an appropriate regimen (use of topical emollients and wash products) that will be used to maintain healthy skin in the future. Baby massage in particular has been shown to enhance the bond between mother and newborn, highlighting that early intervention can support skin health while also being a rewarding experience. Gentle Touch/Early Massage: Apply the lotion with a gentle touch to communicate love to your baby and to create a special bonding moment with skin-to-skin touch. Your touch nurtures baby's social, emotional and physical development. Please take your time to apply consciously the lotion on the whole body of your baby while engaging with her/him. Your touch, light but present, will be consistent across all the face and body areas, it is delicate and soft but more than just applying the lotion. Parents/guardians are using products to help care for their newborn's skin and there is a need to help parents/guardians identify the most appropriate products through research. This study aims to help address this need.
Sex: ALL
Age: 0 Days to 28 Days
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: Newborn babies: * Healthy, full-term, male or female newborns (37+ weeks gestation), with healthy normal skin * Newborn must be within 0-14 days old at Baseline for Phase 1 and within 0-28 days old at Baseline for Phase 2 Mothers: * Mothers carrying singleton pregnancy of greater than or equal to (\>=) 37-weeks gestation * Mother is the one who regularly cares for the newborn. The mother must be available to attend every study visit * Mother must be willing and able to participate in and comply with a study that requires using test products as directed on her newborn throughout study period * Mother must be 18 years of age or older Exclusion Criteria: For both Newborn babies and Mother: * History of a confirmed coronavirus disease 2019 (COVID-19) infection in the last 30 days * Temperature \>=38.0 degree Celsius (°C) /100.4-degree Fahrenheit (°F), measured * Use of fever reducers within the past 2 days of each onsite visit. Exception: The use of fever reducers will be acceptable in this timeframe as long as it for the appropriate indication (example teething, immunization, etc.) and not COVID related as per principal investigator (PI) assessment * Is participating in another clinical study where the participant is currently part of an active intervention/treatment (current or planned during the study period) Newborn babies: * Newborn has a chromosomal abnormality or other syndromic diagnosis * Newborn has major congenital malformations or limb defects * Newborn is currently admitted to a neonatal unit * Newborn with health concerns * Newborn with known allergies or adverse reactions to common topical skincare products * Any condition requiring use of a topical or oral over the counter (OTC) or prescription medication, which in the investigator's judgment makes the subject ineligible or places the subject at risk. Child vitamins are allowed and should be listed on the Medical Information sheet (Health and Eligibility Questionnaire) under the Concurrent Medications section * Newborn with a known condition of asthma or any related breathing problems * Newborn with chronic medical conditions or treatments that could interfere with the study or pose a risk to the newborn (including known immunodeficiency or lung related conditions) * Newborn with active localized or general infections including upper respiratory infections (ear, nose, throat, fever, cough, Et cetera \[etc.\]). * Have been in close contact (exposure within 6 feet/2 meters for a cumulative 15 minutes or more over a 24-hr period) with anyone who has been infected with COVID-19 within the last 14 days or the newborn is under an isolation/quarantine order (prior to enrollment and visit 6) * Per Mother's report of her newborn's symptoms within the past 2 weeks: Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness Mother: * Mother has a known allergies or adverse reactions to the ingredients of any of the test products * Mother is unable to satisfactorily give informed consent for participation * A social issue or logistical reason that, at the discretion of the direct care team, will prevent comfortable study participation by the family * Have been in close contact (exposure within 6 feet/2 meters for a cumulative 15 minutes or more over a 24-hr period) with anyone who has been infected with COVID-19 within the last 14 days or is under an isolation/quarantine order (prior to enrollment and visit 6) * Participants with self-reported symptoms within the past 2 weeks: Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness
- Manchester, Machester, United Kingdom
- Sheffield, United Kingdom