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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Microbiome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change in Skin hydration values
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female
- •3 - 6 months old (up to but not including 7 months, 0 days)
- •Generally in good health based on medical history reported by the subject's parent/LAR.
- •Parent/LAR Is 18 years of age or older and willing/able to present proof of guardianship for the infant subject (i.e., birth certificate, hospital records, adoption record, insurance card, other ID along with valid ID of parent/LAR).
- •Parent/LAR has signed the ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure in English, for the infant to participate in the study.
- •Parent/LAR agrees not to introduce any new products or fragrances on his/her person, on his/her infant (e.g. cleansers, lotions, perfumes, etc.), or in the household environment that the infant may come in contact with (e.g. room fresheners, cleansing agents, etc.) for the duration of the study other than the product provided.
- •Parent/LAR agrees to limit subject's sun exposure and to use appropriate sun protection including clothing, hats and shade as appropriate. Subject's own sunscreen may be used at the parent's/LAR's discretion on exposed areas, but use should be documented. Parent/LAR should make every effort to limit the subject's sun exposure for the duration of the study.
- •Parent/LAR is willing and able to participate in and comply with the study requirements including using the investigational study materials as directed on his/her infant throughout the study period.
- •Parent/LAR agrees not to use the provided products on self or any family member other than the infant subject.
- •Parent/LAR agrees to not allow their infant to participate in another clinical study or product use study during the study duration.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Skin hydration values
Time Frame: Change in skin hydration values from post-baseline (regression) minus Baseline (Day 0) to Day 14.
Skin hydration as assessed by mean Corneometer measurements on the dorsal forearm. Group 2 with baby lotion will also be assessed by dry down of lotion at Baseline (Day 0)
Change in Skin pH values
Time Frame: Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 14.
Skin pH as assessed by mean skin pH on the dorsal forearm at all time points. Group 2 with baby lotion only will be assessed after dry down of the lotion at Baseline (Day 0)
Secondary Outcomes
- Microbial Community Evenness(Baseline (Day 0), Day 14, Day 28 and 3-5 days regression)
- Change in Overall Skin Appearance (Evaluated by PI)(Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days))
- Change in Overall Skin Appearance (Evaluated by parent/LAR)(Change in Overall Skin Appearance from Baseline (Day 0) to Day 14.)
- D-Squame Tapes(Baseline (Day 0) and Day 28)
- Microbial Community Richness(Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression)
- Microbial Community Diversity(Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression)
- Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)(Change in Dryness Scores from Baseline (Day 0) to Regression (3-5 Days).)
- Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)(Change in Redness/Erythema Scores from Baseline (Day 0) to Regression (3-5 Days).)
- Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI)(Change in Rash/Irritation Scores from Baseline (Day 0) to Regression (3-5 Days))
- Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI)(Change in Tactile Roughness Scores from Baseline (Day 0) to Regression (3-5 Days).)
- Change in Skin Irritation (Evaluated by PI)(Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Irritation (Evaluated by parent/LAR)(Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Dryness (Evaluated by PI)(Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Dryness (Evaluated by parent/LAR)(Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Softness (Evaluated by PI)(Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Softness (Evaluated by parent/LAR)(Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Roughness (Evaluated by PI)(Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days))
- Change in Skin Roughness (Evaluated by parent/LAR)(Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days))