Clinical trial NCT03457857: Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiome
Keywords: Microbiome
Microbiota
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 38
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.
* 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.

Primary outcomes:
measure: Change in Skin hydration values
timeFrame: Change in skin hydration values from Baseline (Day 0) to Day 28.
measure: Change in Skin pH values
timeFrame: Change in skin pH values from Baseline (Day 0) to Day 28.
measure: Change in Skin hydration values
timeFrame: Change in skin hydration values from Baseline (Day 0) to Day 14.
measure: Change in Skin hydration values
timeFrame: Change in skin hydration values from post-baseline (regression) minus Baseline (Day 0) to Day 28.
measure: Change in Skin hydration values
timeFrame: Change in skin hydration values from post-baseline (regression) minus Baseline (Day 0) to Day 14.
measure: Change in Skin pH values
timeFrame: Change in skin pH values from Baseline (Day 0) to Day 14.
measure: Change in Skin pH values
timeFrame: Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 28.
measure: Change in Skin pH values
timeFrame: Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 14.
Secondary outcomes:
measure: Change in Overall Skin Appearance (Evaluated by PI)
timeFrame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 28
measure: Change in Overall Skin Appearance (Evaluated by parent/LAR)
timeFrame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 28.
measure: D-Squame Tapes
timeFrame: Baseline (Day 0) and Day 28
measure: Microbial Community Richness
timeFrame: Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression
measure: Microbial Community Diversity
timeFrame: Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression
measure: Microbial Community Evenness
timeFrame: Baseline (Day 0), Day 14, Day 28 and 3-5 days regression
measure: Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)
timeFrame: Change in Dryness Scores from Baseline (Day 0) to Day 28.
measure: Change in Overall Skin Appearance (Evaluated by PI)
timeFrame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 14
measure: Change in Overall Skin Appearance (Evaluated by PI)
timeFrame: Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Overall Skin Appearance (Evaluated by parent/LAR)
timeFrame: Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Overall Skin Appearance (Evaluated by parent/LAR)
timeFrame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 14.
measure: Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)
timeFrame: Change in Dryness Scores from Baseline (Day 0) to Day 14.
measure: Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)
timeFrame: Change in Dryness Scores from Baseline (Day 0) to Regression (3-5 Days).
measure: Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)
timeFrame: Change in Redness/Erythema Scores from Baseline (Day 0) to Day 28.
measure: Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)
timeFrame: Change in Redness/Erythema Scores from Baseline (Day 0) to Day 14.
measure: Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)
timeFrame: Change in Redness/Erythema Scores from Baseline (Day 0) to Regression (3-5 Days).
measure: Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI)
timeFrame: Change in Rash/Irritation Scores from Baseline (Day 0) to Day 28.
measure: Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI)
timeFrame: Change in Rash/Irritation Scores from Baseline (Day 0) to Day 14.
measure: Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI)
timeFrame: Change in Rash/Irritation Scores from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI)
timeFrame: Change in Tactile Roughness Scores from Baseline (Day 0) to Day 28.
measure: Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI)
timeFrame: Change in Tactile Roughness Scores from Baseline (Day 0) to Day 14.
measure: Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI)
timeFrame: Change in Tactile Roughness Scores from Baseline (Day 0) to Regression (3-5 Days).
measure: Change in Skin Irritation (Evaluated by PI)
timeFrame: Change in Skin Irritation from Baseline (Day 0) to Day 28
measure: Change in Skin Irritation (Evaluated by PI)
timeFrame: Change in Skin Irritation from Baseline (Day 0) to Day 14
measure: Change in Skin Irritation (Evaluated by PI)
timeFrame: Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Irritation (Evaluated by parent/LAR)
timeFrame: Change in Skin Irritation from Baseline (Day 0) to Day 28
measure: Change in Skin Irritation (Evaluated by parent/LAR)
timeFrame: Change in Skin Irritation from Baseline (Day 0) to Day 14
measure: Change in Skin Irritation (Evaluated by parent/LAR)
timeFrame: Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Dryness (Evaluated by PI)
timeFrame: Change in Skin Dryness from Baseline (Day 0) to Day 28
measure: Change in Skin Dryness (Evaluated by PI)
timeFrame: Change in Skin Dryness from Baseline (Day 0) to Day 14.
measure: Change in Skin Dryness (Evaluated by PI)
timeFrame: Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Dryness (Evaluated by parent/LAR)
timeFrame: Change in Skin Dryness from Baseline (Day 0) to Day 28
measure: Change in Skin Dryness (Evaluated by parent/LAR)
timeFrame: Change in Skin Dryness from Baseline (Day 0) to Day 14.
measure: Change in Skin Dryness (Evaluated by parent/LAR)
timeFrame: Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Softness (Evaluated by PI)
timeFrame: Change in Skin Softness from Baseline (Day 0) to Day 28
measure: Change in Skin Softness (Evaluated by PI)
timeFrame: Change in Skin Softness from Baseline (Day 0) to Day 14
measure: Change in Skin Softness (Evaluated by PI)
timeFrame: Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Softness (Evaluated by parent/LAR)
timeFrame: Change in Skin Softness from Baseline (Day 0) to Day 28
measure: Change in Skin Softness (Evaluated by parent/LAR)
timeFrame: Change in Skin Softness from Baseline (Day 0) to Day 14.
measure: Change in Skin Softness (Evaluated by parent/LAR)
timeFrame: Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Roughness (Evaluated by PI)
timeFrame: Change in Skin Roughness from Baseline (Day 0) to Day 28
measure: Change in Skin Roughness (Evaluated by PI)
timeFrame: Change in Skin Roughness from Baseline (Day 0) to Day 14.
measure: Change in Skin Roughness (Evaluated by PI)
timeFrame: Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days)
measure: Change in Skin Roughness (Evaluated by parent/LAR)
timeFrame: Change in Skin Roughness from Baseline (Day 0) to Day 28
measure: Change in Skin Roughness (Evaluated by parent/LAR)
timeFrame: Change in Skin Roughness from Baseline (Day 0) to Day 14
measure: Change in Skin Roughness (Evaluated by parent/LAR)
timeFrame: Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days)
Other outcomes:
measure: Number of participants who provide information about their families at Day 31 - Day 33 (Regression)
timeFrame: Questionnaire Data from Day 31 to Day 33
Locations:
city: Skillman
country: United States
facility: Johnson & Johnson Consumer Experience Center
state: New Jersey
Study officials:
affiliation: SourceOne Technical Solution
name: Lee Jumbelic, BS
role: PRINCIPAL_INVESTIGATOR
References: