The purpose of this study is to evaluate the skin tolerance, instrumental efficacy, and perceived product efficacy of a whole-body balm on newborns (0-28 days old).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
28
Balm will be applied to cover newborn's entire body (while avoiding the mouth, eyes, diaper area, and scalp), and gently massaged onto the skin until the balm is fully absorbed.
Wash and shampoo will be used to cleanse newborn baby using an "in tub" bathing method.
CenExcel JBR
Salt Lake City, Utah, United States
Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures
Change from baseline after 4 weeks of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation.
Time frame: Change from baseline after 4 weeks
Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures
Change from baseline after 7 days of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation.
Time frame: Change from baseline after 7 days
Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
Change from baseline after 7 days of product use in Corneometer and TEWL measurements will be reported. The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. Readings are proportional to the dielectric constant of the surface layers of the skin, and the results are displayed in arbitrary "Corneometer units" ranging from 0 to 120, with increasing values corresponding to more hydrated skin. TEWL is a equipment with open chamber TEWL probes to measure the TEWL of the skin. The non-invasive probe contains two sensors that measure the temperature and relative humidity at two fixed points along the axis normal to the skin surface.
Time frame: Change from baseline after 7 days
Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements
Change from baseline after 4 weeks of product use in Corneometer and TEWL measurements will be reported. The Corneometer measures moisture content in the stratum corneum by an electrical capacitance method. Readings are proportional to the dielectric constant of the surface layers of the skin, and the results are displayed in arbitrary "Corneometer units" ranging from 0 to 120, with increasing values corresponding to more hydrated skin. TEWL is a equipment with open chamber TEWL probes to measure the TEWL of the skin. The non-invasive probe contains two sensors that measure the temperature and relative humidity at two fixed points along the axis normal to the skin surface.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Change from baseline after 4 weeks
Number of Response Options for Each Question in the Parental Questionnaire
Number of response options for each question in the parental questionnaire will be reported. Parental questionnaire will be completed by the parent participants which include the questions about "how much do you agree after using balm" where 1 indicates 'strongly disagree', 2 indicates 'somewhat disagree', 3 indicates ;neither agree or disagree', 4 indicates 'somewhat agree', 5 indicates 'strongly agree'.
Time frame: Day 28
Percentage of All Response Options for Each Question in the Parental Questionnaire
Percentage of all response options for each question in the parental questionnaire will be reported. parental questionnaire will be completed by the parent participants which include the questions about "how much do you agree after using balm" where 1 indicates 'strongly disagree', 2 indicates 'somewhat disagree', 3 indicates ;neither agree or disagree', 4 indicates 'somewhat agree', 5 indicates 'strongly agree'.
Time frame: Day 28