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

NCT03457857 | Completed

• 1 other identifier: CO-170929100633-SBCT
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiome

Keywords

Microbiome; Microbiota

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (46)

• Change in Overall Skin Appearance (Evaluated by PI)

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

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

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

• D-Squame Tapes

  Baseline (Day 0) and Day 28

• Microbial Community Richness

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

• Microbial Community Diversity

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

Other Outcomes (1)

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

  Questionnaire Data from Day 31 to Day 33

Study Arms (2)

Group 1 - Cleanser

OTHER

Regimen with Baby Cleanser Only

Other: Cleanser

Group 2 - Cleanser and Lotion

OTHER

Regimen containing Baby Cleanser/Shampoo and Baby Lotion

Other: Cleanser and Lotion

Interventions

Cleanser OTHER

Cosmetic Baby Cleanser/Shampoo

Group 1 - Cleanser

Cleanser and Lotion OTHER

Cosmetic Baby Cleanser/Shampoo and Baby Lotion

Group 2 - Cleanser and Lotion

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Johnson & Johnson Consumer Experience Center

Skillman, New Jersey, 08558, United States

Location

Related Links

• Related Info

Study Officials

• Lee Jumbelic, BS

  SourceOne Technical Solution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This study will be evaluator-blinded, so the PI/expert graders will not know which group (Group 1 or Group 2) each subject is in. Personnel dispensing the IPs or supervising IP use will not participate in the evaluation of subjects in order to minimize potential bias. IPs will be kept separate from the site personnel involved in assessing or evaluating the subjects, and subjects will be instructed not to discuss their assigned IPs with the PI/expert graders or other subjects. To keep the evaluator blinded, the study staff will keep the grading forms separate from the bulk of the source documents so the evaluator will not have access to the sheets that indicate randomization and the study staff will instruct the subjects/LAR to not say anything about what product they are using.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 8, 2018
• Study Start: January 10, 2018
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)