Postnatal Skin PhysiologyNCT01131403
Clinical Analysis of the Influence of Using the Skin Care Products on the Diaper Area in Comparison with Using a Cotton Wool Cloth, Moistened with Clear Water on the Skin Physiology of the Newborns from the 1st Day to the 4th Week of Life
An observational study of Postnatal Skin Physiology, run by Kathrin HILLMANN.
Trial summary
Study design: The purpose of the present study is to analyse of the influence of the application of the skin care products on the diaper area (Factor A) and the application of a cotton wool cloth, moistened with clear water on the diaper area (Faktor B) on the skin barrier function of the newborns during the first… Read more about this study
- Who is it for?
- Ages 0 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Postnatal Skin Physiology
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Oct 2007
- Phase
- Observational
- 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 0 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: group of 40 healthy full-term newborn babies
Who may be able to join
- All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:
- Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
- Written informed parental consent
Who cannot join
- Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage
- Newborns with known immunodeficiency
- Newborns with pre-existing skin disease with eruptions covering more than 50% of body surface i.e. congenital ichthyosis, congenital candidiasis
- Newborn has relevant skin maceration, which influence the measurements or is communicable i.e. urticaria or herpes
- Any acutely or chronically ill newborn with temperatures below 35°C or above 40°C
- Newborn is taking part in another study or is during a term of exclusion of a study
About this study
Official title: Standardized Skin Care Regimen in the Diaper Area: a Prospective, Randomized Clinical Study on Skin Barrier Function and Epidermal IL-1α
Study design:
The purpose of the present study is to analyse of the influence of the application of the skin care products on the diaper area (Factor A) and the application of a cotton wool cloth, moistened with clear water on the diaper area (Faktor B) on the skin barrier function of the newborns during the first four weeks. Additionally, the microbiological colonisation of the skin will be observed. After four weeks all infants in both groups will obtain wet wipe and after 8 weeks a facultative measurement will be performed.
Read more
Primary and secondary end points:
In the present study, as a primary end point TEWL on the buttock was chosen, because the significant difference between the infants who were bathed and washed in the previous study was found.
Secondary end points are the TEWL on the other measuring points, pH-value and SCH. Additionally, secondary end points are the D-Squame method and the cytokine measurement with Sebutapes.
Hypotheses:
The intention of the study is to evaluate, whether the using of wet wipe on the diaper area has an influence on the TEWL of the newborns. The following hypotheses are present below:
H0 (Null hypothesis): The TEWL is indistinguishable between infants who get cleaned with wet wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper area, i.e.
TEWL clear water is equal TEWL wet wipe against H1 (Alternative hypothesis - bilateral): The TEWL is distinguishable between infants who get cleaned with wet wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper area, i.e.
TEWL clear water is not equal TEWL wet wipe
Read the detailed description
Method and number of subjects:
Monocenter, prospective, randomized study with two parallel groups. To get reliable results, the number of male and female newborns to be included in this study is 40.
The group of 40 healthy full-term newborn babies will be divided into 2 groups:
Number of groups and subjects Application of skin care products
- 01-19 Using of wet wipe during the diaper changes
- 20-40 Using a cotton wool cloth, moistened with clear water during the diaper changes. The measurement take place at the Clinical Research Center for Hair and Skin Physiology, at the Department of Dermatology, Campus Charité Mitte and also at the Department of Neonatology Campus Charité Mitte, Charité-Universitätsmedizin Berlin.
Study plan:
Application:
All newborns will obtain a standard skin care, according to division into one of the followings groups: it will be used wet wipe during the diaper changes or a cotton wool cloth moistened with clear water. Additionally, the infants of both groups will be bathed twice a week according to following standard schema. The infant will be submerged in bathtub half filled with water, up to the shoulder.The water temperature should be ca. 370C, pH 7.9-8.2 and the bathing should not require longer than 5 minutes.
Inclusion criteria:
All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:
- Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
- Written informed parental consent
Non-inclusion criteria:
- Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage
- Newborns with known immunodeficiency
- Newborns with pre-existing skin disease with eruptions covering more than 50% of body surface i.e. congenital ichthyosis, congenital candidiasis
- Newborn has relevant skin maceration, which influence the measurements or is communicable i.e. urticaria or herpes
- Any acutely or chronically ill newborn with temperatures below 35°C or above 40°C
- Newborn is taking part in another study or is during a term of exclusion of a study.
- Conditions
- Postnatal Skin Physiology
- Keywords
- IL-1α, skin care; baby wet wipes; full-term newborn; skin barrier function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BW= using baby wipes and CW= using cotton wool | Not described | |
| wet wipe, cotton wool | Group 1 (BW),(n= 01-19):Using of wet wipe during the diaper changes Group 2 (CW),(n=20-40):Using a cotton wool cloth, moistened with clear water during the diaper changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEWL
TEWL= transepidermal waterloss
Measured: second day of life, 14 day of life and 28 day of life
Secondary outcomes (5)
pH
skin pH
Measured: second day of life, 14 day of life and 28 day of life
SCH
SCH= stratum corneum hydration
Measured: 2nd, 14th and 28th day of life
D-Squame
D-Squame= special adhesive skin foils
Measured: 2nd, 14th and 28th day of life
Interleukin-1α
Interleukin 1 alpha= cytokine
Measured: 2nd, 14th and 28th day of life
microbiological colonisation
microbiological colonisation of umbilical an buttock region
Measured: 2nd, 14th and 28th day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal Skin PhysiologyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathrin HILLMANN
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson GmbH
- Responsible party
- Sponsor-investigator, Kathrin HILLMANN, Charite University, Berlin, Germany
- Investigators
- Ulrike Blume-Peytavi, MD, PhD, Principal investigator, Department of Dermatology, Charite-Universitätsmedizin, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131403
- Sponsor's protocol ID
- CRC/wet wipe
- Status last verified
- May 2007
- First submitted
- 26 May 2010
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Skin Care Regimen in the Diaper Area: a Prospective, Randomized Clinical Study on Skin Barrier Function and Epidermal IL-1α
- ClinicalTrials.gov ID
- NCT01131403
- Acronym / sponsor ID
- CRC/wet wipe
- Conditions
- Postnatal Skin Physiology
- Keywords
- IL-1α, skin care; baby wet wipes; full-term newborn; skin barrier function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kathrin HILLMANNUniversity, hospital or other
- Collaborators
- Johnson & Johnson GmbH
- Study start
- May 2007 (actual)
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 May 2010 (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.
Study design:
The purpose of the present study is to analyse of the influence of the application of the skin care products on the diaper area (Factor A) and the application of a cotton wool cloth, moistened with clear water on the diaper area (Faktor B) on the skin barrier function of the newborns during the first four weeks. Additionally, the microbiological colonisation of the skin will be observed. After four weeks all infants in both groups will obtain wet wipe and after 8 weeks a facultative measurement will be performed.
Primary and secondary end points:
In the present study, as a primary end point TEWL on the buttock was chosen, because the significant difference between the infants who were bathed and washed in the previous study was found.
Secondary end points are the TEWL on the other measuring points, pH-value and SCH. Additionally, secondary end points are the D-Squame method and the cytokine measurement with Sebutapes.
Hypotheses:
The intention of the study is to evaluate, whether the using of wet wipe on the diaper area has an influence on the TEWL of the newborns. The following hypotheses are present below:
H0 (Null hypothesis): The TEWL is indistinguishable between infants who get cleaned with wet wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper area, i.e.
TEWL clear water is equal TEWL wet wipe against H1 (Alternative hypothesis - bilateral): The TEWL is distinguishable between infants who get cleaned with wet wipe on the diaper area and infants who get cleaned with a cotton wool cloth, moistened with clear water on the diaper area, i.e.
TEWL clear water is not equal TEWL wet wipe
Detailed description
Method and number of subjects:
Monocenter, prospective, randomized study with two parallel groups. To get reliable results, the number of male and female newborns to be included in this study is 40.
The group of 40 healthy full-term newborn babies will be divided into 2 groups:
Number of groups and subjects Application of skin care products
- 01-19 Using of wet wipe during the diaper changes
- 20-40 Using a cotton wool cloth, moistened with clear water during the diaper changes. The measurement take place at the Clinical Research Center for Hair and Skin Physiology, at the Department of Dermatology, Campus Charité Mitte and also at the Department of Neonatology Campus Charité Mitte, Charité-Universitätsmedizin Berlin.
Study plan:
Application:
All newborns will obtain a standard skin care, according to division into one of the followings groups: it will be used wet wipe during the diaper changes or a cotton wool cloth moistened with clear water. Additionally, the infants of both groups will be bathed twice a week according to following standard schema. The infant will be submerged in bathtub half filled with water, up to the shoulder.The water temperature should be ca. 370C, pH 7.9-8.2 and the bathing should not require longer than 5 minutes.
Inclusion criteria:
All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:
- Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
- Written informed parental consent
Non-inclusion criteria:
- Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage
- Newborns with known immunodeficiency
- Newborns with pre-existing skin disease with eruptions covering more than 50% of body surface i.e. congenital ichthyosis, congenital candidiasis
- Newborn has relevant skin maceration, which influence the measurements or is communicable i.e. urticaria or herpes
- Any acutely or chronically ill newborn with temperatures below 35°C or above 40°C
- Newborn is taking part in another study or is during a term of exclusion of a study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BW= using baby wipes and CW= using cotton wool | – | – |
| wet wipe, cotton wool | – | –Group 1 (BW),(n= 01-19):Using of wet wipe during the diaper changes Group 2 (CW),(n=20-40):Using a cotton wool cloth, moistened with clear water during the diaper changes. |
Who may qualify
- Ages
- 0 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- group of 40 healthy full-term newborn babies
Key inclusion criteria (3 listed)
- All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:
Key exclusion criteria (6 listed)
- Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TEWL
Time frame: second day of life, 14 day of life and 28 day of life
TEWL= transepidermal waterloss
5 secondary outcomes
pH
Time frame: second day of life, 14 day of life and 28 day of life
SCH
Time frame: 2nd, 14th and 28th day of life
D-Squame
Time frame: 2nd, 14th and 28th day of life
Interleukin-1α
Time frame: 2nd, 14th and 28th day of life
microbiological colonisation
Time frame: 2nd, 14th and 28th day of life
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 13 Feb 2025.
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.
Ulrike Blume-Peytavi, MD, PhD principal investigator
Department of Dermatology, Charite-Universitätsmedizin, Berlin
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Skin Physiology, run by Kathrin HILLMANN.
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 3 inclusion and 6 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
TEWL (time frame: second day of life, 14 day of life and 28 day of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.