<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981056</url>
  </required_header>
  <id_info>
    <org_study_id>JB-05-2012-31</org_study_id>
    <nct_id>NCT02981056</nct_id>
  </id_info>
  <brief_title>A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants</brief_title>
  <official_title>A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer and Personal Products Worldwide</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai China-Norm Management Consulting co.,LTD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi Bio-regenerative Biotechnology co.LTD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to investigate the effects of different skincare regimens on&#xD;
      infants (0-6 months old at the start of the study), specifically focusing on moisturization&#xD;
      effect. Outcome measures include moisturization, skin pH, skin barrier, physiological&#xD;
      parameters, reactivity and skin microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, single-blind, parallel study in healthy, full-term, male or female&#xD;
      infants aged 0-6 months at the start of the study. The objective of the study is to&#xD;
      investigate the effects of different skincare regimens on infants (0-6 months old at the&#xD;
      start of the study), specifically focusing on moisturization effect. Outcome measures include&#xD;
      moisturization, skin pH, skin barrier, physiological parameters, reactivity and skin&#xD;
      microbiome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin surface moisture</measure>
    <time_frame>3 months</time_frame>
    <description>Skin surface moisture content via capacitance measurements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin deep hydration</measure>
    <time_frame>3 months</time_frame>
    <description>Skin deep Hydration and water content via measurement of dielectric constant of the skin to a depth of 500 microns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trans-epidermis water loss (TEWL)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of TEWL/Skin surface moisture to reflect skin barrier function</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin pH value</measure>
    <time_frame>3 months</time_frame>
    <description>Skin pH value measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin roughness</measure>
    <time_frame>3 months</time_frame>
    <description>Skin roughness estimated from digital images.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatological assessments</measure>
    <time_frame>3 months</time_frame>
    <description>Dermatological grading of overall skin condition, softness, dryness, redness (erythema), rash (irritation) and tactile roughness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Caregiver assessments</measure>
    <time_frame>3 months</time_frame>
    <description>Parent/Caregiver rating of overall skin condition, softness, dryness, redness (erythema), rash (irritation) and tactile roughness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin microbiome</measure>
    <time_frame>3 months</time_frame>
    <description>Skin microbiome analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin bio-marker</measure>
    <time_frame>3 months</time_frame>
    <description>Skin bio-marker analysis via tape stripping.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Baby Skin Development</condition>
  <arm_group>
    <arm_group_label>Wash + Lotion regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Johnson's Baby Top-To-Toe Wash (Ideally 7 times a week, at least 5 times a week) + Johnson's Baby Lotion (at least once a day).&#xD;
The products/treatment were used for a period of 3 months, and the products were placed on skin and with attention to applying the products on the arms, legs and torso.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water + Lotion regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Water (in lieu of bathing products) + Johnson's Baby Lotion (at least once a day).&#xD;
The products/treatment were used for a period of 3 months, and the products were placed on skin and with attention to applying the products on the arms, legs and torso.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Water (in lieu of bathing products) only. The products/treatment were used for a period of 3 months, and the products were placed on skin and with attention to applying the products on the arms, legs and torso.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Johnson's Baby Top-To-Toe Wash</intervention_name>
    <description>During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: Ideally 7 times a week, at least 5 times a week, no more than once in the same day.</description>
    <arm_group_label>Wash + Lotion regimen</arm_group_label>
    <other_name>JB Wash</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Johnson's Baby Lotion</intervention_name>
    <description>During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: at least once a day, no more than twice in the same day.</description>
    <arm_group_label>Wash + Lotion regimen</arm_group_label>
    <arm_group_label>Water + Lotion regimen</arm_group_label>
    <other_name>JB Lotion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water (in lieu of bathing products)</intervention_name>
    <description>During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: Ideally 7 times a week, at least 5 times a week, no more than once in the same day.</description>
    <arm_group_label>Water + Lotion regimen</arm_group_label>
    <arm_group_label>Water only</arm_group_label>
    <other_name>Water</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Study Population: Healthy, full-term, male or female aged 0-6 months old at the start&#xD;
             of the study. The newborn must not suffer from any pre-existing conditions (including&#xD;
             skin conditions) that can adversely affect the outcome of the study.&#xD;
&#xD;
          2. The participating parent/legal guardian is the one who regularly cares for the&#xD;
             newborn. This parent/legal guardian must be willing and able to follow all study&#xD;
             directions, accept skin examination and commit to all follow-up visits for the&#xD;
             duration of the study. The participating parent/legal guardian must agree to complete&#xD;
             a daily diary, as well as questionnaires about use of the test product at each trial&#xD;
             visit.&#xD;
&#xD;
               1. For Cell No.1, the participating parent/legal guardian must be willing to bathe&#xD;
                  the newborn with the provided baby wash during every bath, at least 5 times a&#xD;
                  week throughout the remainder of the study. Test wash should be used no more than&#xD;
                  once in the same day.&#xD;
&#xD;
                  The participating parent/legal guardian must be willing to apply the provided&#xD;
                  test lotion at least once per day, in the morning. When bathing the newborn, the&#xD;
                  test lotion should be used after bathing. If the newborn is bathed in the&#xD;
                  afternoon or evening (at least 6 hours after the first lotion application), the&#xD;
                  test lotion is to be re-applied after bathing. Test lotion should be used no more&#xD;
                  than twice in the same day.&#xD;
&#xD;
               2. For Cell No.2, the participating parent/legal guardian must be willing to bathe&#xD;
                  the newborn with water only during every bath, at least 5 times a week throughout&#xD;
                  the remainder of the study.&#xD;
&#xD;
                  The participating parent/legal guardian must be willing to apply the provided&#xD;
                  test lotion at least once per day, in the morning. When bathing the newborn, the&#xD;
                  test lotion should be used after bathing. If the newborn is bathed in the&#xD;
                  afternoon or evening (at least 6 hours after the first lotion application), the&#xD;
                  test lotion is to be re-applied after bathing. Test lotion should be used no more&#xD;
                  than twice in the same day.&#xD;
&#xD;
               3. For Cell No.3, the participating parent/legal guardian must be willing to bathe&#xD;
                  the newborn with water only during every bath, at least 5 times a week throughout&#xD;
                  the remainder of the study but not more than once a day.&#xD;
&#xD;
             The participating parent/legal guardian must be willing to not apply any body&#xD;
             moisturizer to the newborn throughout the study.&#xD;
&#xD;
          3. The participating parent/legal guardian must be willing to read an IRB-approved&#xD;
             informed consent agreement in Chinese, have all study related questions answered and&#xD;
             to sign 2 copies of the agreement on behalf of his/her minor child (1 to retain and 1&#xD;
             for the study file).&#xD;
&#xD;
          4. Participating parent/legal guardian must be willing to complete a medical history and&#xD;
             eligibility questionnaire related to his/her child, and to sign a photographic&#xD;
             release, and a confidentiality agreement.&#xD;
&#xD;
          5. Participating parent/legal guardian must understand/agree that all of the following&#xD;
             inclusion criteria must be met for 1 per household to be enrolled and participate in&#xD;
             the study. One newborn in the household is eligible to participate in the study.&#xD;
             Newborn is the only subject in the household who will participate in the study and&#xD;
             routinely treated with the test materials alone.&#xD;
&#xD;
          6. Participating, adult parent/legal guardian of the subject must be 18 years of age or&#xD;
             older and must be willing to present proof of guardianship (i.e., birth certificate,&#xD;
             insurance card) at screening/baseline visit.&#xD;
&#xD;
          7. Participating parent/legal guardian must be willing to cooperate and participate by&#xD;
             following study requirements for the duration of the study.&#xD;
&#xD;
          8. Participating parent/legal guardian must be willing to not bathe their newborn at&#xD;
             least 12 hours prior to each clinic visit and to have the newborn wear loose-fitting&#xD;
             clothing to each visit to accommodate procedures.&#xD;
&#xD;
          9. Participating parent/legal guardian must be willing for their newborn to have clean&#xD;
             skin on baseline visit and all follow-up visits.&#xD;
&#xD;
         10. Parent/legal guardian must be willing to not apply any product to the newborn for 24&#xD;
             hours before visit until after the visit is completed.&#xD;
&#xD;
         11. Parent/legal guardian must be willing to replace the regular wash and&#xD;
             lotion/moisturizer with the assigned products in this trial. Parent/legal guardian&#xD;
             must continue to use newborn's regular brand of shampoo (but limit the use of shampoo&#xD;
             on head/hair only), wipes/powder, and diaper rash ointment/cream as long as they have&#xD;
             been using the product for at least 1 month prior to the start of the study.&#xD;
&#xD;
         12. Parent/legal guardian must agree not to use the provided test products on any other&#xD;
             family member (other than the newborn participant) for the duration of the study.&#xD;
&#xD;
         13. Parent/legal guardian must be willing to use the product as a direct-to-skin with hand&#xD;
             application. Parent/legal guardian must be willing to use the wash product without&#xD;
             pouring it into the bath.&#xD;
&#xD;
         14. Parent/legal guardian must agree not to introduce any new fragrances on his/her&#xD;
             person, or on his/her newborn (e.g. cleansers, lotions, perfumes, etc.), or in the&#xD;
             household environment (e.g. room fresheners, cleansing agents, etc.) for the duration&#xD;
             of the study.&#xD;
&#xD;
         15. Parent/legal guardian must agree not to expose his/her newborn participating in the&#xD;
             study to excessive sun exposure. Parent/legal guardian must agree for the newborn to&#xD;
             avoid extended sun exposure during the peak periods of 11 AM to 4 PM. If newborn is&#xD;
             briefly exposed to the sun, parent/legal guardian will make every attempt to use&#xD;
             protective clothing. No use of sunscreen is allowed throughout study participation.&#xD;
&#xD;
         16. Parent/legal guardian must agree not to permit their newborn from participating in&#xD;
             another study for the duration of the study.&#xD;
&#xD;
         17. Parent/legal guardian must agree for the newborn to avoid the beach during the course&#xD;
             of the study, and any activities at or in a swimming pool should be documented in the&#xD;
             daily diary.&#xD;
&#xD;
         18. Evidence of a personally signed and dated Informed Consent document indicating that&#xD;
             the Parent/legal guardian has been informed of all pertinent aspects of the trial.&#xD;
&#xD;
         19. Parent/legal guardian who is willing and able to comply with scheduled visits, study&#xD;
             procedures, and other trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any disease or condition of the skin (i.e. dermatitis, eczema, psoriasis, rosacea)&#xD;
             that the Investigator deems inappropriate for participation.&#xD;
&#xD;
          2. Any newborn with clinically determined moderate to severe dryness (&gt;2.0) or clinically&#xD;
             determined erythema (&gt;0.5), rash (&gt;0.5), or an overall skin condition which, in the&#xD;
             Investigator's judgment, makes the subject ineligible or places the subject at risk&#xD;
             will not be enrolled in the study.&#xD;
&#xD;
          3. Any condition requiring use of a topical or oral OTC or prescription medication,&#xD;
             which, in the investigator's judgment, makes the subject ineligible or places the&#xD;
             subject at risk (e.g. antibiotics or any other medications that may cause&#xD;
             gastrointestinal distress/diarrhea that will affect skin condition/cause&#xD;
             irritation/rash of genital/buttocks area). Child vitamins are allowed and should be&#xD;
             listed on the Medical Information sheet under the Concurrent Medications section.&#xD;
&#xD;
          4. Individuals currently involved in another clinical study of any type, or planning to&#xD;
             participate in another clinical study of any type during this study.&#xD;
&#xD;
          5. Newborn participant who exhibits or is known to have atopic dermatitis, eczema, or&#xD;
             other inflammatory disease, or mild to severe diaper rash or skin diseases/conditions&#xD;
             that in the opinion of the investigator may affect the evaluation of study product or&#xD;
             place the newborn at undue risk.&#xD;
&#xD;
          6. Newborn participant or parent/legal guardian who has experienced unusual&#xD;
             hypersensitivity or allergic reactivity to fragrances and/or reaction/irritation to&#xD;
             skin care toiletry products, or who has known allergies/sensitivities to ingredients&#xD;
             in the provided test products.&#xD;
&#xD;
          7. Newborn participant or parent/legal guardian with a known condition of asthma or any&#xD;
             related breathing problems and/or for whom there is a family history of asthma.&#xD;
&#xD;
          8. Newborn participant with chronic medical conditions or treatments that could interfere&#xD;
             with the study or pose a risk to the newborn (including known immunodeficiency or lung&#xD;
             related conditions).&#xD;
&#xD;
          9. Newborn participant with active localized or general infections including upper&#xD;
             respiratory infections (ear, nose, throat, fever, cough, etc.).&#xD;
&#xD;
         10. Conditions that may interfere with the evaluation of the trial results, e.g., medical&#xD;
             characteristics, diseases, or therapy that may interfere with the effect of the&#xD;
             investigational product or with the evaluation of efficacy or safety variables. The&#xD;
             conditions may also include concurrent use of another investigational product or prior&#xD;
             use of an investigational product or approved medication or other drug within a&#xD;
             defined period prior to trial enrollment.&#xD;
&#xD;
         11. Conditions for which subjects should be excluded for safety reasons, e.g., medical&#xD;
             characteristics, disease, or therapy that may constitute contraindications or risks in&#xD;
             connection with the use of the investigational product or the specified methods of&#xD;
             evaluation.&#xD;
&#xD;
         12. Participation in other clinical trials within 30 days before the current trial begins&#xD;
             and/or during trial participation&#xD;
&#xD;
         13. Other medical conditions that may increase the risk associated with trial&#xD;
             participation or may interfere with the interpretation of trial results and, in the&#xD;
             judgment of the investigator, would make the subject inappropriate for entry into this&#xD;
             trial.&#xD;
&#xD;
         14. Parent/Legal guardian of the newborn is an employee of the investigator or study&#xD;
             center or is a family member of the employees or the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lin Ma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Children's Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>De Paepe K, Houben E, Adam R, Wiesemann F, Rogiers V. Validation of the VapoMeter, a closed unventilated chamber system to assess transepidermal water loss vs. the open chamber Tewameter. Skin Res Technol. 2005 Feb;11(1):61-9. doi: 10.1111/j.1600-0846.2005.00101.x.</citation>
    <PMID>15691261</PMID>
  </reference>
  <reference>
    <citation>Fluhr JW, Darlenski R, Lachmann N, Baudouin C, Msika P, De Belilovsky C, Hachem JP. Infant epidermal skin physiology: adaptation after birth. Br J Dermatol. 2012 Mar;166(3):483-90. doi: 10.1111/j.1365-2133.2011.10659.x. Epub 2012 Jan 19.</citation>
    <PMID>21967466</PMID>
  </reference>
  <reference>
    <citation>Saijo S, Tagami H. Dry skin of newborn infants: functional analysis of the stratum corneum. Pediatr Dermatol. 1991 Jun;8(2):155-9. doi: 10.1111/j.1525-1470.1991.tb00308.x.</citation>
    <PMID>1923986</PMID>
  </reference>
  <reference>
    <citation>Kvenshagen B, Jacobsen M, Halvorsen R. Atopic dermatitis in premature and term children. Arch Dis Child. 2009 Mar;94(3):202-5. doi: 10.1136/adc.2008.142869. Epub 2008 Oct 1.</citation>
    <PMID>18829619</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skincare regimens</keyword>
  <keyword>Skin moisturization</keyword>
  <keyword>Skin barrier</keyword>
  <keyword>Skin development</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981056
org study id: JB-05-2012-31
nct id: NCT02981056
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of the study is to investigate the effects of different skincare regimens on
      infants (0-6 months old at the start of the study), specifically focusing on moisturization
      effect. Outcome measures include moisturization, skin pH, skin barrier, physiological
      parameters, reactivity and skin microbiome.
This is a single-center, single-blind, parallel study in healthy, full-term, male or female
      infants aged 0-6 months at the start of the study. The objective of the study is to
      investigate the effects of different skincare regimens on infants (0-6 months old at the
      start of the study), specifically focusing on moisturization effect. Outcome measures include
      moisturization, skin pH, skin barrier, physiological parameters, reactivity and skin
      microbiome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Skin surface moisture
time frame: 3 months
description: Skin surface moisture content via capacitance measurements.
measure: Skin deep hydration
time frame: 3 months
description: Skin deep Hydration and water content via measurement of dielectric constant of the skin to a depth of 500 microns.
measure: Trans-epidermis water loss (TEWL)
time frame: 3 months
measure: Ratio of TEWL/Skin surface moisture to reflect skin barrier function
time frame: 3 months
measure: Skin pH value
time frame: 3 months
description: Skin pH value measurement.
measure: Skin roughness
time frame: 3 months
description: Skin roughness estimated from digital images.
measure: Dermatological assessments
time frame: 3 months
description: Dermatological grading of overall skin condition, softness, dryness, redness (erythema), rash (irritation) and tactile roughness.
measure: Parent/Caregiver assessments
time frame: 3 months
description: Parent/Caregiver rating of overall skin condition, softness, dryness, redness (erythema), rash (irritation) and tactile roughness.
measure: Skin microbiome
time frame: 3 months
description: Skin microbiome analysis.
measure: Skin bio-marker
time frame: 3 months
description: Skin bio-marker analysis via tape stripping.
arm group label: Wash + Lotion regimen
arm group type: Active Comparator
description: Johnson's Baby Top-To-Toe Wash (Ideally 7 times a week, at least 5 times a week) + Johnson's Baby Lotion (at least once a day).
The products/treatment were used for a period of 3 months, and the products were placed on skin and with attention to applying the products on the arms, legs and torso.
arm group label: Water + Lotion regimen
arm group type: Active Comparator
description: Water (in lieu of bathing products) + Johnson's Baby Lotion (at least once a day).
The products/treatment were used for a period of 3 months, and the products were placed on skin and with attention to applying the products on the arms, legs and torso.
arm group label: Water only
arm group type: Active Comparator
description: Water (in lieu of bathing products) only. The products/treatment were used for a period of 3 months, and the products were placed on skin and with attention to applying the products on the arms, legs and torso.
intervention type: Other
intervention name: Johnson's Baby Top-To-Toe Wash
description: During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: Ideally 7 times a week, at least 5 times a week, no more than once in the same day.
arm group label: Wash + Lotion regimen
other name: JB Wash
intervention type: Other
intervention name: Johnson's Baby Lotion
description: During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: at least once a day, no more than twice in the same day.
arm group label: Wash + Lotion regimen
arm group label: Water + Lotion regimen
other name: JB Lotion
intervention type: Other
intervention name: Water (in lieu of bathing products)
description: During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: Ideally 7 times a week, at least 5 times a week, no more than once in the same day.
arm group label: Water + Lotion regimen
arm group label: Water only
other name: Water
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Lin Ma, PhD
role: Principal Investigator
affiliation: Beijing Children's Hospital
facility: 
country: China
citation: Boireau-Adamezyk E, Baillet-Guffroy A, Stamatas GN. Age-dependent changes in stratum corneum barrier function. Skin Res Technol. 2014 Nov;20(4):409-15. doi: 10.1111/srt.12132. Epub 2014 Feb 12.
PMID: 24517174
citation: Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17.
PMID: 18200056
citation: Stamatas GN, Nikolovski J, Mack MC, Kollias N. Infant skin physiology and development during the first years of life: a review of recent findings based on in vivo studies. Int J Cosmet Sci. 2011 Feb;33(1):17-24. doi: 10.1111/j.1468-2494.2010.00611.x. Epub 2010 Aug 30.
PMID: 20807257
citation: Walters RM, Khanna P, Chu M, Mack MC. Developmental Changes in Skin Barrier and Structure during the First 5 Years of Life. Skin Pharmacol Physiol. 2016;29(3):111-8. doi: 10.1159/000444805. Epub 2016 May 5.
PMID: 27161444
citation: Stamatas GN, Zerweck C, Grove G, Martin KM. Documentation of impaired epidermal barrier in mild and moderate diaper dermatitis in vivo using noninvasive methods. Pediatr Dermatol. 2011 Mar-Apr;28(2):99-107. doi: 10.1111/j.1525-1470.2011.01308.x.
PMID: 21504443
citation: Stamatas GN, Tierney NK. Diaper dermatitis: etiology, manifestations, prevention, and management. Pediatr Dermatol. 2014 Jan-Feb;31(1):1-7. doi: 10.1111/pde.12245. Epub 2013 Nov 14.
PMID: 24224482
citation: Blume-Peytavi U, Hauser M, Lunnemann L, Stamatas GN, Kottner J, Garcia Bartels N. Prevention of diaper dermatitis in infants--a literature review. Pediatr Dermatol. 2014 Jul-Aug;31(4):413-29. doi: 10.1111/pde.12348. Epub 2014 May 29.
PMID: 24890321
citation: Atherton D, Mills K. What can be done to keep babies' skin healthy? RCM Midwives. 2004 Jul;7(7):288-90.
PMID: 15314924
citation: Mack MC, Chu MR, Tierney NK, Ruvolo E Jr, Stamatas GN, Kollias N, Bhagat K, Ma L, Martin KM. Water-Holding and Transport Properties of Skin Stratum Corneum of Infants and Toddlers Are Different from Those of Adults: Studies in Three Geographical Regions and Four Ethnic Groups. Pediatr Dermatol. 2016 May;33(3):275-82. doi: 10.1111/pde.12798. Epub 2016 Feb 10.
PMID: 26860213
citation: Blume-Peytavi U, Lavender T, Jenerowicz D, Ryumina I, Stalder JF, Torrelo A, Cork MJ. Recommendations from a European Roundtable Meeting on Best Practice Healthy Infant Skin Care. Pediatr Dermatol. 2016 May;33(3):311-21. doi: 10.1111/pde.12819. Epub 2016 Feb 26.
PMID: 26919683
citation: Blume-Peytavi U, Hauser M, Stamatas GN, Pathirana D, Garcia Bartels N. Skin care practices for newborns and infants: review of the clinical evidence for best practices. Pediatr Dermatol. 2012 Jan-Feb;29(1):1-14. doi: 10.1111/j.1525-1470.2011.01594.x. Epub 2011 Oct 20.
PMID: 22011065
citation: Garcia Bartels N, Scheufele R, Prosch F, Schink T, Proquitte H, Wauer RR, Blume-Peytavi U. Effect of standardized skin care regimens on neonatal skin barrier function in different body areas. Pediatr Dermatol. 2010 Jan-Feb;27(1):1-8. doi: 10.1111/j.1525-1470.2009.01068.x. Erratum In: Pediatr Dermatol. 2010 Mar 1;27(2):221.
PMID: 20199402
citation: Dizon MV, Galzote C, Estanislao R, Mathew N, Sarkar R. Tolerance of baby cleansers in infants: a randomized controlled trial. Indian Pediatr. 2010 Nov;47(11):959-63. doi: 10.1007/s13312-010-0161-8. Epub 2010 Mar 15.
PMID: 20453263
citation: Blume-Peytavi U, Cork MJ, Faergemann J, Szczapa J, Vanaclocha F, Gelmetti C. Bathing and cleansing in newborns from day 1 to first year of life: recommendations from a European round table meeting. J Eur Acad Dermatol Venereol. 2009 Jul;23(7):751-9. doi: 10.1111/j.1468-3083.2009.03140.x.
PMID: 19646134
citation: Gfatter R, Hackl P, Braun F. Effects of soap and detergents on skin surface pH, stratum corneum hydration and fat content in infants. Dermatology. 1997;195(3):258-62. doi: 10.1159/000245955.
PMID: 9407174
citation: Atrux-Tallau N, Huynh NT, Gardette L, Pailler-Mattei C, Zahouani H, Viviant E, Hirsch H, Marek H, Falson F, Pirot F. Effects of physical and chemical treatments upon biophysical properties and micro-relief of human skin. Arch Dermatol Res. 2008 Jun;300(5):243-51. doi: 10.1007/s00403-008-0849-y. Epub 2008 Apr 2.
PMID: 18386023
citation: Giusti F, Martella A, Bertoni L, Seidenari S. Skin barrier, hydration, and pH of the skin of infants under 2 years of age. Pediatr Dermatol. 2001 Mar-Apr;18(2):93-6. doi: 10.1046/j.1525-1470.2001.018002093.x.
PMID: 11358544
citation: Mayrovitz HN, Bernal M, Brlit F, Desfor R. Biophysical measures of skin tissue water: variations within and among anatomical sites and correlations between measures. Skin Res Technol. 2013 Feb;19(1):47-54. doi: 10.1111/srt.12000. Epub 2012 Oct 9.
PMID: 23046199
citation: Alanen E, Nuutinen J, Nicklen K, Lahtinen T, Monkkonen J. Measurement of hydration in the stratum corneum with the MoistureMeter and comparison with the Corneometer. Skin Res Technol. 2004 Feb;10(1):32-7. doi: 10.1111/j.1600-0846.2004.00050.x.
PMID: 14731246
citation: De Paepe K, Houben E, Adam R, Wiesemann F, Rogiers V. Validation of the VapoMeter, a closed unventilated chamber system to assess transepidermal water loss vs. the open chamber Tewameter. Skin Res Technol. 2005 Feb;11(1):61-9. doi: 10.1111/j.1600-0846.2005.00101.x.
PMID: 15691261
citation: Fluhr JW, Darlenski R, Lachmann N, Baudouin C, Msika P, De Belilovsky C, Hachem JP. Infant epidermal skin physiology: adaptation after birth. Br J Dermatol. 2012 Mar;166(3):483-90. doi: 10.1111/j.1365-2133.2011.10659.x. Epub 2012 Jan 19.
PMID: 21967466
citation: Saijo S, Tagami H. Dry skin of newborn infants: functional analysis of the stratum corneum. Pediatr Dermatol. 1991 Jun;8(2):155-9. doi: 10.1111/j.1525-1470.1991.tb00308.x.
PMID: 1923986
citation: Kvenshagen B, Jacobsen M, Halvorsen R. Atopic dermatitis in premature and term children. Arch Dis Child. 2009 Mar;94(3):202-5. doi: 10.1136/adc.2008.142869. Epub 2008 Oct 1.
PMID: 18829619
responsible party type: Sponsor
sharing ipd: No