Microbiome Clinical Trial
Official title:
A Single Center, Five Week, Evaluator Blinded, Clinical Trial Evaluating Two Cleansing and/or Moisturizing Regimens on the Skin of Healthy Infants Using Clinical, Instrumental, D-Squame Tape, Microbiome and Parental Assessments
This study is to assess the impact of two skincare regimens on the cutaneous microbiome and skin physiology of healthy male and female infants, ages 3-6 months using clinical, instrumental, D-Squame tape, microbiome and parental assessments over a five-week period.
Skin cleansing has been demonstrated as a simple strategy to help keep skin healthy. There
are many types of cleansing and moisturizing routines that have been shown to have different
effects on the skin barrier such as reducing sebum and exogenous contaminants, controlling
odors, and affecting the skin microbiome.1 A previous study in an adult population showed
that use of a mild surfactant cleanser had less of an impact on the skin barrier than a
liquid castile soap (data on file ).2 Because infant skin differs from an adult's in
structure, function, and composition3, cleanser and/or lotion regimens may impact the skin
barrier of infants differently.
There is very little information in the literature on how the use of product regimens impacts
the cutaneous microbiome and skin physiology of adults1 and even less about how it impacts
the skin of children.
This study will explore the impact that the use of two regimens - one cleansing and the other
cleansing and moisturizing - has on the holistic skin barrier of infants ages 3-6 months.
The IPs are a baby wash and a baby lotion, which are both cosmetic body products. The
auxiliary product is a commercially available, cosmetic baby body wash.
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