MicrobiomeMicrobiomeNCT03457857
Evaluation of Two Regimens, With Healthy Male and Female Babies, Ages 3-6 Months Old, Using Various Assessments.
A study testing Cleanser and Cleanser and Lotion in people with Microbiome, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Microbiome
- What is being tested?
- Cleanser and Cleanser and Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 11 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johnson & Johnson Consumer Experience Center
Skillman, New Jersey, 08558
About this study
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.
Read the 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.
- Conditions
- Microbiome
- Being tested
- Cleanser, Cleanser and Lotion
- Keywords
- Microbiome, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanserOther
Cosmetic Baby Cleanser/Shampoo
Cleanser and LotionOther
Cosmetic Baby Cleanser/Shampoo and Baby Lotion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Cleanser | Other | Regimen with Baby Cleanser Only Receives: Other: Cleanser |
| Group 2 - Cleanser and Lotion | Other | Regimen containing Baby Cleanser/Shampoo and Baby Lotion Receives: Other: Cleanser and Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 14.
Secondary outcomes (46)
Change in Overall Skin Appearance (Evaluated by PI)
Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start10 Jan 2018
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Jumbelic, BS, Principal investigator, SourceOne Technical Solution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457857
- Sponsor's protocol ID
- CO-170929100633-SBCT
- Acronym
- Microbiome
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03457857
- Acronym / sponsor ID
- Microbiome / CO-170929100633-SBCT
- Conditions
- Microbiome
- Keywords
- Microbiome, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Cleanser | Other | Other: CleanserRegimen with Baby Cleanser Only |
| Group 2 - Cleanser and Lotion | Other | Other: Cleanser and LotionRegimen containing Baby Cleanser/Shampoo and Baby Lotion |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CleanserCosmetic Baby Cleanser/Shampoo | Other | Group 1 - Cleanser |
| Cleanser and LotionCosmetic Baby Cleanser/Shampoo and Baby Lotion | Other | Group 2 - Cleanser and Lotion |
Primary outcome
Change in Skin hydration values
Time frame: Change in skin hydration values from Baseline (Day 0) to Day 28.
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 Baseline (Day 0) to Day 28.
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 hydration values
Time frame: Change in skin hydration values from 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 hydration values
Time frame: Change in skin hydration values from post-baseline (regression) minus Baseline (Day 0) to Day 28.
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
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 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)
Change in Skin pH values
Time frame: Change in skin pH values from post-baseline (regression) minus Baseline (Day 0) to Day 28.
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
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)
46 secondary outcomes
Change in Overall Skin Appearance (Evaluated by PI)
Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 28
Change in Overall Skin Appearance (Evaluated by parent/LAR)
Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 28.
D-Squame Tapes
Time frame: Baseline (Day 0) and Day 28
Microbial Community Richness
Time frame: Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression
Microbial Community Diversity
Time frame: Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression
Microbial Community Evenness
Time frame: Baseline (Day 0), Day 14, Day 28 and 3-5 days regression
Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)
Time frame: Change in Dryness Scores from Baseline (Day 0) to Day 28.
Change in Overall Skin Appearance (Evaluated by PI)
Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 14
Change in Overall Skin Appearance (Evaluated by PI)
Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days)
Change in Overall Skin Appearance (Evaluated by parent/LAR)
Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days)
Change in Overall Skin Appearance (Evaluated by parent/LAR)
Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 14.
Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)
Time frame: Change in Dryness Scores from Baseline (Day 0) to Day 14.
Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)
Time frame: Change in Dryness Scores from Baseline (Day 0) to Regression (3-5 Days).
Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)
Time frame: Change in Redness/Erythema Scores from Baseline (Day 0) to Day 28.
Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)
Time frame: Change in Redness/Erythema Scores from Baseline (Day 0) to Day 14.
Change in Clinical Assessment Evaluation for Redness/Erythema (Evaluated by PI)
Time frame: 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)
Time frame: Change in Rash/Irritation Scores from Baseline (Day 0) to Day 28.
Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI)
Time frame: Change in Rash/Irritation Scores from Baseline (Day 0) to Day 14.
Change in Clinical Assessment Evaluation for Rash/Irritation (Evaluated by PI)
Time frame: 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)
Time frame: Change in Tactile Roughness Scores from Baseline (Day 0) to Day 28.
Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI)
Time frame: Change in Tactile Roughness Scores from Baseline (Day 0) to Day 14.
Change in Clinical Assessment Evaluation for Tactile Roughness (Evaluated by PI)
Time frame: Change in Tactile Roughness Scores from Baseline (Day 0) to Regression (3-5 Days).
Change in Skin Irritation (Evaluated by PI)
Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 28
Change in Skin Irritation (Evaluated by PI)
Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 14
Change in Skin Irritation (Evaluated by PI)
Time frame: Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days)
Change in Skin Irritation (Evaluated by parent/LAR)
Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 28
Change in Skin Irritation (Evaluated by parent/LAR)
Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 14
Change in Skin Irritation (Evaluated by parent/LAR)
Time frame: Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days)
Change in Skin Dryness (Evaluated by PI)
Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 28
Change in Skin Dryness (Evaluated by PI)
Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 14.
Change in Skin Dryness (Evaluated by PI)
Time frame: Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days)
Change in Skin Dryness (Evaluated by parent/LAR)
Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 28
Change in Skin Dryness (Evaluated by parent/LAR)
Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 14.
Change in Skin Dryness (Evaluated by parent/LAR)
Time frame: Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days)
Change in Skin Softness (Evaluated by PI)
Time frame: Change in Skin Softness from Baseline (Day 0) to Day 28
Change in Skin Softness (Evaluated by PI)
Time frame: Change in Skin Softness from Baseline (Day 0) to Day 14
Change in Skin Softness (Evaluated by PI)
Time frame: Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days)
Change in Skin Softness (Evaluated by parent/LAR)
Time frame: Change in Skin Softness from Baseline (Day 0) to Day 28
Change in Skin Softness (Evaluated by parent/LAR)
Time frame: Change in Skin Softness from Baseline (Day 0) to Day 14.
Change in Skin Softness (Evaluated by parent/LAR)
Time frame: Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Jumbelic, BS principal investigator
SourceOne Technical Solution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleanser and Cleanser and Lotion in people with Microbiome, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin hydration values (time frame: Change in skin hydration values from Baseline (Day 0) to Day 28.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.