Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Microbiome

Intervention / Treatment
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* Other: Cleanser
* Other: Cleanser and Lotion


Participation Criteria
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Eligibility Criteria
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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. Parent/LAR agrees to the possible subsequent use of the data in medical or scientific journals and medical or scientific presentation materials and advertising materials. All subject identities will remain confidential. Exclusion Criteria Has known allergies, adverse reactions, or unusual hypersensitivity to common topical skincare products or their components, fragrances, skin care toiletry products or adhesive tapes. Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer, sensitive skin, moderate to severe looking diaper rash). Actively taking any medications, particularly antibiotics either oral or topical, as they may interfere with the study. Any condition requiring use of a topical or oral OTC or prescription medication, which in the Study Physician's judgement makes the subject ineligible or places the subject at risk (e.g. antibiotics such as Amoxicillin, Zithromax, Cefphalexin or any other medications that may cause gastrointestinal distress/diarrhea that will affect skin condition/cause irritation/rash of genital/buttocks area). Infant may not swim, or use hot tubs or pools for the duration of the study. Has Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication as reported by the parent/LAR. Has taken medications that would mask an AE or influence the study results, including: Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory drugs within 3 months before Visit 1 and during the study. Antihistamines within 1 month before Visit 1 and during the study. Receiving systemic or topical medications, which may interfere with study evaluations. Has a history of or a concurrent health condition/situation, which, in the opinion of the PI or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study. Is simultaneously participating in any other type of clinical study or product use study Has had a recent change in dietary intake within 1 week (7 days) prior to study start. Has a known condition of asthma or any related breathing problem and/or for whom there is a family history of asthma. Has an active localized or general infections including upper respiratory infections (ear, nose, throat, fever, cough, etc.). Has excessive scars, which could interfere with expert grader evaluations. Is viewed by the PI or Study Physician as not being able to complete the study. Parent/LAR is pregnant and/or planning to become pregnant during the study or within the next 3 months.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The duration of this trial will be approximately 5 weeks and will consist of a screening visit followed by an approximately 1-week (7-day) washout period; a 4-week (28 day) treatment period with visits conducted at baseline (Day 0, ± 2 days), week 2 (Day 14, ± 2 days), and week 4 (Day 28, ± 2 days); and a regression period with a visit 3-5 days after the week 4 visit. During the one week washout period, subjects will use a commercial available Baby Wash at least 3x per week. For the next 4 weeks, subjects will be randomly assigned to use one of two IP regiments. Subjects in Group 1 will use the Baby Wash & Shampoo at least 3x per week, but no more than once daily. Subjects in Group 2 will use the Baby Wash & Shampoo at least 3x per week, but no more than once daily, plus the Baby Lotion at least once daily. The lotion should be applied after bathing (as applicable). At Visit 4, subjects will begin a 3-5 day regression period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 - Cleanser<br>Regimen with Baby Cleanser Only | Other: Cleanser<br>* Cosmetic Baby Cleanser/Shampoo<br>|
| Other: Group 2 - Cleanser and Lotion<br>Regimen containing Baby Cleanser/Shampoo and Baby Lotion | Other: Cleanser and Lotion<br>* Cosmetic Baby Cleanser/Shampoo and Baby Lotion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skin hydration values | 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 hydration values from Baseline (Day 0) to Day 28. | 
| Change in Skin pH values | 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) | Change in skin pH values from Baseline (Day 0) to Day 28. | 
| Change in Skin hydration values | 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 hydration values from Baseline (Day 0) to Day 14. | 
| Change in Skin hydration values | 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 hydration values from post-baseline (regression) minus Baseline (Day 0) to Day 28. | 
| Change in Skin hydration values | 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 hydration values from post-baseline (regression) minus Baseline (Day 0) to Day 14. | 
| Change in Skin pH values | 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) | Change in skin pH values from Baseline (Day 0) to Day 14. | 
| Change in Skin pH values | 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) | Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 28. | 
| Change in Skin pH values | 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) | Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Skin Appearance (Evaluated by PI) | Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10) | Change in Overall Skin Appearance from Baseline (Day 0) to Day 28 | 
| Change in Overall Skin Appearance (Evaluated by parent/LAR) | Overall Skin Appearance will be evaluated by the parent/LAR on a 10-point Scale ranging from Poor (Score =1) to Excellent (Score =10) | Change in Overall Skin Appearance from Baseline (Day 0) to Day 28. | 
| D-Squame Tapes | D-Squame Tape samples will be taken on the dorsal forearm, which safely removes stratum corneum components, visibility of adhering corneocytes and a metabolomics method. | Baseline (Day 0) and Day 28 | 
| Microbial Community Richness | Microbial Community Richness on the forehead, dorsal forearm and buttock based on the total number of different bacterial taxa detected in the sample. | Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression | 
| Microbial Community Diversity | Microbial Community Diversity on the forehead, dorsal forearm and buttock based on the Shannon Index. | Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression | 
| Microbial Community Evenness | Microbial Community Evenness on the forehead, dorsal forearm and buttock based on Pielou's evenness index. | Baseline (Day 0), Day 14, Day 28 and 3-5 days regression | 
| Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI) | Clinical Assessments for Dryness will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Dryness Scores from Baseline (Day 0) to Day 28. | 
| Change in Overall Skin Appearance (Evaluated by PI) | Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10) | Change in Overall Skin Appearance from Baseline (Day 0) to Day 14 | 
| Change in Overall Skin Appearance (Evaluated by PI) | Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10) | Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Overall Skin Appearance (Evaluated by parent/LAR) | Overall Skin Appearance will be evaluated by the parent/LAR on a 10-point Scale ranging from Poor (Score =1) to Excellent (Score =10) | Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Overall Skin Appearance (Evaluated by parent/LAR) | Overall Skin Appearance will be evaluated by the parent/LAR on a 10-point Scale ranging from Poor (Score =1) to Excellent (Score =10) | Change in Overall Skin Appearance from Baseline (Day 0) to Day 14. | 
| Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI) | Clinical Assessments for Dryness will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Dryness Scores from Baseline (Day 0) to Day 14. | 
| Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI) | Clinical Assessments for Dryness will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the 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) | Clinical Assessments for Redness/Erythema will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Redness/Erythema Scores from Baseline (Day 0) to Day 28. | 
| Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI) | Clinical Assessments for Redness/Erythema will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Redness/Erythema Scores from Baseline (Day 0) to Day 14. | 
| Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI) | Clinical Assessments for Redness/Erythema will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the 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) | Clinical Assessments for Rash/Irritation will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Rash/Irritation Scores from Baseline (Day 0) to Day 28. | 
| Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI) | Clinical Assessments for Rash/Irritation will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Rash/Irritation Scores from Baseline (Day 0) to Day 14. | 
| Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI) | Clinical Assessments for Rash/Irritation will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the 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) | Clinical Assessments for Tactile Roughness will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Tactile Roughness Scores from Baseline (Day 0) to Day 28. | 
| Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI) | Clinical Assessments for Tactile Roughness will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Tactile Roughness Scores from Baseline (Day 0) to Day 14. | 
| Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI) | Clinical Assessments for Tactile Roughness will be evaluated on a 4-point Scale from 0 = None, 1 = Mild, 2 = Moderate and 3= Severe globally by the PI | Change in Tactile Roughness Scores from Baseline (Day 0) to Regression (3-5 Days). | 
| Change in Skin Irritation (Evaluated by PI) | Skin Irritation will be evaluated by the PI on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10) | Change in Skin Irritation from Baseline (Day 0) to Day 28 | 
| Change in Skin Irritation (Evaluated by PI) | Skin Irritation will be evaluated by the PI on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10) | Change in Skin Irritation from Baseline (Day 0) to Day 14 | 
| Change in Skin Irritation (Evaluated by PI) | Skin Irritation will be evaluated by the PI on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10) | Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Irritation (Evaluated by parent/LAR) | Skin Irritation will be evaluated by the parent/LAR on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10) | Change in Skin Irritation from Baseline (Day 0) to Day 28 | 
| Change in Skin Irritation (Evaluated by parent/LAR) | Skin Irritation will be evaluated by the parent/LAR on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10) | Change in Skin Irritation from Baseline (Day 0) to Day 14 | 
| Change in Skin Irritation (Evaluated by parent/LAR) | Skin Irritation will be evaluated by the parent/LAR on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10) | Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Dryness (Evaluated by PI) | Skin Dryness will be evaluated by the PI on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10) | Change in Skin Dryness from Baseline (Day 0) to Day 28 | 
| Change in Skin Dryness (Evaluated by PI) | Skin Dryness will be evaluated by the PI on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10) | Change in Skin Dryness from Baseline (Day 0) to Day 14. | 
| Change in Skin Dryness (Evaluated by PI) | Skin Dryness will be evaluated by the PI on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10) | Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Dryness (Evaluated by parent/LAR) | Skin Dryness will be evaluated by the parent/LAR on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10) | Change in Skin Dryness from Baseline (Day 0) to Day 28 | 
| Change in Skin Dryness (Evaluated by parent/LAR) | Skin Dryness will be evaluated by the parent/LAR on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10) | Change in Skin Dryness from Baseline (Day 0) to Day 14. | 
| Change in Skin Dryness (Evaluated by parent/LAR) | Skin Dryness will be evaluated by the parent/LAR on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10) | Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Softness (Evaluated by PI) | Skin Softness will be evaluated by the PI on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10) | Change in Skin Softness from Baseline (Day 0) to Day 28 | 
| Change in Skin Softness (Evaluated by PI) | Skin Softness will be evaluated by the PI on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10) | Change in Skin Softness from Baseline (Day 0) to Day 14 | 
| Change in Skin Softness (Evaluated by PI) | Skin Softness will be evaluated by the PI on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10) | Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Softness (Evaluated by parent/LAR) | Skin Softness will be evaluated by the parent/LAR on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10) | Change in Skin Softness from Baseline (Day 0) to Day 28 | 
| Change in Skin Softness (Evaluated by parent/LAR) | Skin Softness will be evaluated by the parent/LAR on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10) | Change in Skin Softness from Baseline (Day 0) to Day 14. | 
| Change in Skin Softness (Evaluated by parent/LAR) | Skin Softness will be evaluated by the parent/LAR on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10) | Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Roughness (Evaluated by PI) | Skin Roughness will be evaluated by the PI on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10) | Change in Skin Roughness from Baseline (Day 0) to Day 28 | 
| Change in Skin Roughness (Evaluated by PI) | Skin Roughness will be evaluated by the PI on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10) | Change in Skin Roughness from Baseline (Day 0) to Day 14. | 
| Change in Skin Roughness (Evaluated by PI) | Skin Roughness will be evaluated by the PI on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10) | Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days) | 
| Change in Skin Roughness (Evaluated by parent/LAR) | Skin Roughness will be evaluated by the parent/LAR on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10) | Change in Skin Roughness from Baseline (Day 0) to Day 28 | 
| Change in Skin Roughness (Evaluated by parent/LAR) | Skin Roughness will be evaluated by the parent/LAR on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10) | Change in Skin Roughness from Baseline (Day 0) to Day 14 | 
| Change in Skin Roughness (Evaluated by parent/LAR) | Skin Roughness will be evaluated by the parent/LAR on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10) | Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Microbiota