Baby Skin DevelopmentNCT02981056

A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants

A study testing Johnson's Baby Top-To-Toe Wash, Johnson's Baby Lotion and Water (in lieu of bathing products) in people with Baby Skin Development, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages Up to 6 monthsHealthy volunteers can take part
Conditions the study is for: Baby Skin Development
What is being tested?: Johnson's Baby Top-To-Toe Wash, Johnson's Baby Lotion and Water (in lieu of bathing products)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: Jun 2013to Nov 2013
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 Up to 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Study Population: Healthy, full-term, male or female aged 0-6 months old at the start of the study. The newborn must not suffer from any pre-existing conditions (including skin conditions) that can adversely affect the outcome of the study.
The participating parent/legal guardian is the one who regularly cares for the newborn. This parent/legal guardian must be willing and able to follow all study directions, accept skin examination and commit to all follow-up visits for the duration of the study. The participating parent/legal guardian must agree to complete a daily diary, as well as questionnaires about use of the test product at each trial visit.
For Cell No.1, the participating parent/legal guardian must be willing to bathe the newborn with the provided baby wash during every bath, at least 5 times a week throughout the remainder of the study. Test wash should be used no more than once in the same day.
The participating parent/legal guardian must be willing to apply the provided test lotion at least once per day, in the morning. When bathing the newborn, the test lotion should be used after bathing. If the newborn is bathed in the afternoon or evening (at least 6 hours after the first lotion application), the test lotion is to be re-applied after bathing. Test lotion should be used no more than twice in the same day.
For Cell No.2, the participating parent/legal guardian must be willing to bathe the newborn with water only during every bath, at least 5 times a week throughout the remainder of the study.
The participating parent/legal guardian must be willing to apply the provided test lotion at least once per day, in the morning. When bathing the newborn, the test lotion should be used after bathing. If the newborn is bathed in the afternoon or evening (at least 6 hours after the first lotion application), the test lotion is to be re-applied after bathing. Test lotion should be used no more than twice in the same day.

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For Cell No.3, the participating parent/legal guardian must be willing to bathe the newborn with water only during every bath, at least 5 times a week throughout the remainder of the study but not more than once a day.
The participating parent/legal guardian must be willing to not apply any body moisturizer to the newborn throughout the study.
The participating parent/legal guardian must be willing to read an IRB-approved informed consent agreement in Chinese, have all study related questions answered and to sign 2 copies of the agreement on behalf of his/her minor child (1 to retain and 1 for the study file).
Participating parent/legal guardian must be willing to complete a medical history and eligibility questionnaire related to his/her child, and to sign a photographic release, and a confidentiality agreement.
Participating parent/legal guardian must understand/agree that all of the following inclusion criteria must be met for 1 per household to be enrolled and participate in the study. One newborn in the household is eligible to participate in the study. Newborn is the only subject in the household who will participate in the study and routinely treated with the test materials alone.
Participating, adult parent/legal guardian of the subject must be 18 years of age or older and must be willing to present proof of guardianship (i.e., birth certificate, insurance card) at screening/baseline visit.
Participating parent/legal guardian must be willing to cooperate and participate by following study requirements for the duration of the study.
Participating parent/legal guardian must be willing to not bathe their newborn at least 12 hours prior to each clinic visit and to have the newborn wear loose-fitting clothing to each visit to accommodate procedures.
Participating parent/legal guardian must be willing for their newborn to have clean skin on baseline visit and all follow-up visits.
Parent/legal guardian must be willing to not apply any product to the newborn for 24 hours before visit until after the visit is completed.
Parent/legal guardian must be willing to replace the regular wash and lotion/moisturizer with the assigned products in this trial. Parent/legal guardian must continue to use newborn's regular brand of shampoo (but limit the use of shampoo on head/hair only), wipes/powder, and diaper rash ointment/cream as long as they have been using the product for at least 1 month prior to the start of the study.
Parent/legal guardian must agree not to use the provided test products on any other family member (other than the newborn participant) for the duration of the study.
Parent/legal guardian must be willing to use the product as a direct-to-skin with hand application. Parent/legal guardian must be willing to use the wash product without pouring it into the bath.
Parent/legal guardian must agree not to introduce any new fragrances on his/her person, or on his/her newborn (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, etc.) for the duration of the study.
Parent/legal guardian must agree not to expose his/her newborn participating in the study to excessive sun exposure. Parent/legal guardian must agree for the newborn to avoid extended sun exposure during the peak periods of 11 AM to 4 PM. If newborn is briefly exposed to the sun, parent/legal guardian will make every attempt to use protective clothing. No use of sunscreen is allowed throughout study participation.
Parent/legal guardian must agree not to permit their newborn from participating in another study for the duration of the study.
Parent/legal guardian must agree for the newborn to avoid the beach during the course of the study, and any activities at or in a swimming pool should be documented in the daily diary.
Evidence of a personally signed and dated Informed Consent document indicating that the Parent/legal guardian has been informed of all pertinent aspects of the trial.
Parent/legal guardian who is willing and able to comply with scheduled visits, study procedures, and other trial procedures.

Who cannot join

Any disease or condition of the skin (i.e. dermatitis, eczema, psoriasis, rosacea) that the Investigator deems inappropriate for participation.
Any newborn with clinically determined moderate to severe dryness (>2.0) or clinically determined erythema (>0.5), rash (>0.5), or an overall skin condition which, in the Investigator's judgment, makes the subject ineligible or places the subject at risk will not be enrolled in the study.
Any condition requiring use of a topical or oral OTC or prescription medication, which, in the investigator's judgment, makes the subject ineligible or places the subject at risk (e.g. antibiotics or any other medications that may cause gastrointestinal distress/diarrhea that will affect skin condition/cause irritation/rash of genital/buttocks area). Child vitamins are allowed and should be listed on the Medical Information sheet under the Concurrent Medications section.
Individuals currently involved in another clinical study of any type, or planning to participate in another clinical study of any type during this study.
Newborn participant who exhibits or is known to have atopic dermatitis, eczema, or other inflammatory disease, or mild to severe diaper rash or skin diseases/conditions that in the opinion of the investigator may affect the evaluation of study product or place the newborn at undue risk.
Newborn participant or parent/legal guardian who has experienced unusual hypersensitivity or allergic reactivity to fragrances and/or reaction/irritation to skin care toiletry products, or who has known allergies/sensitivities to ingredients in the provided test products.

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Newborn participant or parent/legal guardian with a known condition of asthma or any related breathing problems and/or for whom there is a family history of asthma.
Newborn participant with chronic medical conditions or treatments that could interfere with the study or pose a risk to the newborn (including known immunodeficiency or lung related conditions).
Newborn participant with active localized or general infections including upper respiratory infections (ear, nose, throat, fever, cough, etc.).
Conditions that may interfere with the evaluation of the trial results, e.g., medical characteristics, diseases, or therapy that may interfere with the effect of the investigational product or with the evaluation of efficacy or safety variables. The conditions may also include concurrent use of another investigational product or prior use of an investigational product or approved medication or other drug within a defined period prior to trial enrollment.
Conditions for which subjects should be excluded for safety reasons, e.g., medical characteristics, disease, or therapy that may constitute contraindications or risks in connection with the use of the investigational product or the specified methods of evaluation.
Participation in other clinical trials within 30 days before the current trial begins and/or during trial participation
Other medical conditions that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Parent/Legal guardian of the newborn is an employee of the investigator or study center or is a family member of the employees or the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045

Other trials in China

About this study

Read the detailed description

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.

Conditions: Baby Skin Development
Being tested: Johnson's Baby Top-To-Toe Wash, Johnson's Baby Lotion, Water (in lieu of bathing products)
Keywords: Skincare regimens, Skin moisturization, Skin barrier, Skin development

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Johnson's Baby Top-To-Toe WashOther
Also called JB Wash
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.
Johnson's Baby LotionOther
Also called JB Lotion
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.
Water (in lieu of bathing products)Other
Also called Water
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.

Study groups in NCT02981056
Study group	Role	What they receive
Wash + Lotion regimen	Active comparator	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. Receives: Other: Johnson's Baby Top-To-Toe Wash; Other: Johnson's Baby Lotion
Water + Lotion regimen	Active comparator	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. Receives: Other: Johnson's Baby Lotion; Other: Water (in lieu of bathing products)
Water only	Active comparator	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. Receives: Other: Water (in lieu of bathing products)

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin surface moisture
Skin surface moisture content via capacitance measurements.
Measured: 3 months

Secondary outcomes (9)

Skin deep hydration
Skin deep Hydration and water content via measurement of dielectric constant of the skin to a depth of 500 microns.
Measured: 3 months
Trans-epidermis water loss (TEWL)
Measured: 3 months
Ratio of TEWL/Skin surface moisture to reflect skin barrier function
Measured: 3 months
Skin pH value
Skin pH value measurement.
Measured: 3 months
Skin roughness
Skin roughness estimated from digital images.
Measured: 3 months
Dermatological assessments
Dermatological grading of overall skin condition, softness, dryness, redness (erythema), rash (irritation) and tactile roughness.
Measured: 3 months
Parent/Caregiver assessments
Parent/Caregiver rating of overall skin condition, softness, dryness, redness (erythema), rash (irritation) and tactile roughness.
Measured: 3 months
Skin microbiome
Skin microbiome analysis.
Measured: 3 months
Skin bio-marker
Skin bio-marker analysis via tape stripping.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Nov 2013

First posted2 Dec 2016 (estimated)
Study startJun 2013
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Baby Skin DevelopmentStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981056
Sponsor's protocol ID: JB-05-2012-31
Status last verified: Nov 2016
First submitted: 30 Nov 2016
Last updated: 2 Dec 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 24517174
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.
PubMed 18200056
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.
PubMed 20807257
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.
PubMed 27161444
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.
PubMed 21504443
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.
PubMed 24224482
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.
PubMed 24890321
Atherton D, Mills K. What can be done to keep babies' skin healthy? RCM Midwives. 2004 Jul;7(7):288-90.
PubMed 15314924
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.
PubMed 26860213
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.
PubMed 26919683
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.
PubMed 22011065
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.
PubMed 20199402
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.
PubMed 20453263
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.
PubMed 19646134
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.
PubMed 9407174

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Baby Skin Development trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants
ClinicalTrials.gov ID: NCT02981056
Acronym / sponsor ID: JB-05-2012-31
Conditions: Baby Skin Development
Keywords: Skincare regimens, Skin moisturization, Skin barrier, Skin development
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
Collaborators: Beijing Children's Hospital, Shanghai China-Norm Management Consulting co.,LTD, Fudan University, Shaanxi Bio-regenerative Biotechnology co.LTD
Study start: Jun 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 2 Dec 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Wash + Lotion regimen	Active comparator	Other: Johnson's Baby Top-To-Toe Wash, Other: Johnson's Baby LotionJohnson'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.
Water + Lotion regimen	Active comparator	Other: Johnson's Baby Lotion, Other: Water (in lieu of bathing products)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.
Water only	Active comparator	Other: Water (in lieu of bathing products)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.

Who may qualify

Ages: Up to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (25 listed)

Study Population: Healthy, full-term, male or female aged 0-6 months old at the start of the study. The newborn must not suffer from any pre-existing conditions (including skin conditions) that can adversely affect the outcome of the study.
The participating parent/legal guardian is the one who regularly cares for the newborn. This parent/legal guardian must be willing and able to follow all study directions, accept skin examination and commit to all follow-up visits for the duration of the study. The participating parent/legal guardian must agree to complete a daily diary, as well as questionnaires about use of the test product at each trial visit.
The participating parent/legal guardian must be willing to apply the provided test lotion at least once per day, in the morning. When bathing the newborn, the test lotion should be used after bathing. If the newborn is bathed in the afternoon or evening (at least 6 hours after the first lotion application), the test lotion is to be re-applied after bathing. Test lotion should be used no more than twice in the same day.
The participating parent/legal guardian must be willing to apply the provided test lotion at least once per day, in the morning. When bathing the newborn, the test lotion should be used after bathing. If the newborn is bathed in the afternoon or evening (at least 6 hours after the first lotion application), the test lotion is to be re-applied after bathing. Test lotion should be used no more than twice in the same day.
The participating parent/legal guardian must be willing to not apply any body moisturizer to the newborn throughout the study.

Key exclusion criteria (14 listed)

Any disease or condition of the skin (i.e. dermatitis, eczema, psoriasis, rosacea) that the Investigator deems inappropriate for participation.
Any newborn with clinically determined moderate to severe dryness (>2.0) or clinically determined erythema (>0.5), rash (>0.5), or an overall skin condition which, in the Investigator's judgment, makes the subject ineligible or places the subject at risk will not be enrolled in the study.
Any condition requiring use of a topical or oral OTC or prescription medication, which, in the investigator's judgment, makes the subject ineligible or places the subject at risk (e.g. antibiotics or any other medications that may cause gastrointestinal distress/diarrhea that will affect skin condition/cause irritation/rash of genital/buttocks area). Child vitamins are allowed and should be listed on the Medical Information sheet under the Concurrent Medications section.
Individuals currently involved in another clinical study of any type, or planning to participate in another clinical study of any type during this study.
Newborn participant who exhibits or is known to have atopic dermatitis, eczema, or other inflammatory disease, or mild to severe diaper rash or skin diseases/conditions that in the opinion of the investigator may affect the evaluation of study product or place the newborn at undue risk.

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
Johnson's Baby Top-To-Toe WashAlso: JB WashDuring 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.	Other	Wash + Lotion regimen
Johnson's Baby LotionAlso: JB LotionDuring 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.	Other	Wash + Lotion regimen, Water + Lotion regimen
Water (in lieu of bathing products)Also: WaterDuring 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.	Other	Water + Lotion regimen, Water only

Primary outcome

Skin surface moisture
Time frame: 3 months
Skin surface moisture content via capacitance measurements.

9 secondary outcomes

Skin deep hydration
Time frame: 3 months
Trans-epidermis water loss (TEWL)
Time frame: 3 months
Ratio of TEWL/Skin surface moisture to reflect skin barrier function
Time frame: 3 months
Skin pH value
Time frame: 3 months
Skin roughness
Time frame: 3 months
Dermatological assessments
Time frame: 3 months
Parent/Caregiver assessments
Time frame: 3 months
Skin microbiome
Time frame: 3 months
Skin bio-marker
Time frame: 3 months

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 2 Dec 2016.
Background: PubMed 24517174Boireau-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.
Background: PubMed 18200056Nikolovski 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.
Background: PubMed 20807257Stamatas 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.
Background: PubMed 27161444Walters 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.
Background: PubMed 21504443Stamatas 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.
Background: PubMed 24224482Stamatas 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.
Background: PubMed 24890321Blume-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.
Background: PubMed 15314924Atherton D, Mills K. What can be done to keep babies' skin healthy? RCM Midwives. 2004 Jul;7(7):288-90.
Background: PubMed 26860213Mack 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.
Background: PubMed 26919683Blume-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.
Background: PubMed 22011065Blume-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.
Background: PubMed 20199402Garcia 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.
Individual participant dataSharing planned: No

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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.

Lin Ma, PhD principal investigator

Beijing Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 25 inclusion and 14 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 2 Dec 2016. 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 China. 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?

Skin surface moisture (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02981056, which also lists 23 linked publications.

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 2 Dec 2016.