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Completed

NCT Number: NCT03457857

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

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Key information

Conditions

Microbiome

Age range

3 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johnson & Johnson Consumer Experience Center

Skillman, New Jersey, 08558, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cleanser

Other

Cosmetic Baby Cleanser/Shampoo

Cleanser and Lotion

Other

Cosmetic Baby Cleanser/Shampoo and Baby Lotion

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

  1. Change in Overall Skin Appearance (Evaluated by PI)

    Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 28

    Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10)

  2. Change in Overall Skin Appearance (Evaluated by parent/LAR)

    Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 28.

    Overall Skin Appearance will be evaluated by the parent/LAR on a 10-point Scale ranging from Poor (Score =1) to Excellent (Score =10)

  3. D-Squame Tapes

    Time frame: Baseline (Day 0) and Day 28

    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.

  4. Microbial Community Richness

    Time frame: Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression

    Microbial Community Richness on the forehead, dorsal forearm and buttock based on the total number of different bacterial taxa detected in the sample.

  5. Microbial Community Diversity

    Time frame: Baseline (Day 0), Day 14, Day 28 and 3-5 days Regression

    Microbial Community Diversity on the forehead, dorsal forearm and buttock based on the Shannon Index.

  6. Microbial Community Evenness

    Time frame: Baseline (Day 0), Day 14, Day 28 and 3-5 days regression

    Microbial Community Evenness on the forehead, dorsal forearm and buttock based on Pielou's evenness index.

  7. Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)

    Time frame: Change in Dryness Scores from Baseline (Day 0) to Day 28.

    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

  8. Change in Overall Skin Appearance (Evaluated by PI)

    Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 14

    Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10)

  9. Change in Overall Skin Appearance (Evaluated by PI)

    Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Regression (3-5 Days)

    Overall Skin Appearance on a 10 Point Scale from Poor (Score =1) to Excellent (Score =10)

  10. 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)

    Overall Skin Appearance will be evaluated by the parent/LAR on a 10-point Scale ranging from Poor (Score =1) to Excellent (Score =10)

  11. Change in Overall Skin Appearance (Evaluated by parent/LAR)

    Time frame: Change in Overall Skin Appearance from Baseline (Day 0) to Day 14.

    Overall Skin Appearance will be evaluated by the parent/LAR on a 10-point Scale ranging from Poor (Score =1) to Excellent (Score =10)

  12. Change in Clinical Assessment Evaluation for Dryness (Evaluated by PI)

    Time frame: Change in Dryness Scores from Baseline (Day 0) to Day 14.

    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

  13. 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).

    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

  14. 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.

    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

  15. 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.

    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

  16. 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).

    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

  17. 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.

    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

  18. 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.

    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

  19. 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)

    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

  20. 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.

    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

  21. 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.

    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

  22. 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).

    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

  23. Change in Skin Irritation (Evaluated by PI)

    Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 28

    Skin Irritation will be evaluated by the PI on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10)

  24. Change in Skin Irritation (Evaluated by PI)

    Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 14

    Skin Irritation will be evaluated by the PI on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10)

  25. Change in Skin Irritation (Evaluated by PI)

    Time frame: Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days)

    Skin Irritation will be evaluated by the PI on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10)

  26. Change in Skin Irritation (Evaluated by parent/LAR)

    Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 28

    Skin Irritation will be evaluated by the parent/LAR on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10)

  27. Change in Skin Irritation (Evaluated by parent/LAR)

    Time frame: Change in Skin Irritation from Baseline (Day 0) to Day 14

    Skin Irritation will be evaluated by the parent/LAR on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10)

  28. Change in Skin Irritation (Evaluated by parent/LAR)

    Time frame: Change in Skin Irritation from Baseline (Day 0) to Regression (3-5 Days)

    Skin Irritation will be evaluated by the parent/LAR on a 10 Point Scale from Very Irritated (Score =1) to Not Irritated (Score =10)

  29. Change in Skin Dryness (Evaluated by PI)

    Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 28

    Skin Dryness will be evaluated by the PI on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10)

  30. Change in Skin Dryness (Evaluated by PI)

    Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 14.

    Skin Dryness will be evaluated by the PI on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10)

  31. Change in Skin Dryness (Evaluated by PI)

    Time frame: Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days)

    Skin Dryness will be evaluated by the PI on a 10 Point Scale from Very Dry (Score =1) to No Visible Dryness (Score =10)

  32. Change in Skin Dryness (Evaluated by parent/LAR)

    Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 28

    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)

  33. Change in Skin Dryness (Evaluated by parent/LAR)

    Time frame: Change in Skin Dryness from Baseline (Day 0) to Day 14.

    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)

  34. Change in Skin Dryness (Evaluated by parent/LAR)

    Time frame: Change in Skin Dryness from Baseline (Day 0) to Regression (3-5 Days)

    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)

  35. Change in Skin Softness (Evaluated by PI)

    Time frame: Change in Skin Softness from Baseline (Day 0) to Day 28

    Skin Softness will be evaluated by the PI on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10)

  36. Change in Skin Softness (Evaluated by PI)

    Time frame: Change in Skin Softness from Baseline (Day 0) to Day 14

    Skin Softness will be evaluated by the PI on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10)

  37. Change in Skin Softness (Evaluated by PI)

    Time frame: Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days)

    Skin Softness will be evaluated by the PI on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10)

  38. Change in Skin Softness (Evaluated by parent/LAR)

    Time frame: Change in Skin Softness from Baseline (Day 0) to Day 28

    Skin Softness will be evaluated by the parent/LAR on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10)

  39. Change in Skin Softness (Evaluated by parent/LAR)

    Time frame: Change in Skin Softness from Baseline (Day 0) to Day 14.

    Skin Softness will be evaluated by the parent/LAR on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10)

  40. Change in Skin Softness (Evaluated by parent/LAR)

    Time frame: Change in Skin Softness from Baseline (Day 0) to Regression (3-5 Days)

    Skin Softness will be evaluated by the parent/LAR on a 10 Point Scale from Not Soft (Score =1) to Very Soft (Score =10)

  41. Change in Skin Roughness (Evaluated by PI)

    Time frame: Change in Skin Roughness from Baseline (Day 0) to Day 28

    Skin Roughness will be evaluated by the PI on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10)

  42. Change in Skin Roughness (Evaluated by PI)

    Time frame: Change in Skin Roughness from Baseline (Day 0) to Day 14.

    Skin Roughness will be evaluated by the PI on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10)

  43. Change in Skin Roughness (Evaluated by PI)

    Time frame: Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days)

    Skin Roughness will be evaluated by the PI on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10)

  44. Change in Skin Roughness (Evaluated by parent/LAR)

    Time frame: Change in Skin Roughness from Baseline (Day 0) to Day 28

    Skin Roughness will be evaluated by the parent/LAR on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10)

  45. Change in Skin Roughness (Evaluated by parent/LAR)

    Time frame: Change in Skin Roughness from Baseline (Day 0) to Day 14

    Skin Roughness will be evaluated by the parent/LAR on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10)

  46. Change in Skin Roughness (Evaluated by parent/LAR)

    Time frame: Change in Skin Roughness from Baseline (Day 0) to Regression (3-5 Days)

    Skin Roughness will be evaluated by the parent/LAR on a 10 Point Scale from Very Rough (Score =1) to Very Smooth (Score =10)

Other outcomes

  1. Number of participants who provide information about their families at Day 31 - Day 33 (Regression)

    Time frame: Questionnaire Data from Day 31 to Day 33

    Parent/LAR will complete a questionnaire about Breastfeeding, Delivery, Touch and Environment. There are no baseline measures for comparison.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study 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

Acronym: Microbiome

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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