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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

NCT01131403 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2025-02-13

No results posted yet for this study

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 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

Conditions

  • Postnatal Skin Physiology

Sponsors & Collaborators

  • Johnson & Johnson GmbH

    collaborator INDUSTRY

  • Kathrin HILLMANN

    lead OTHER

Principal Investigators

  • Ulrike Blume-Peytavi, MD, PhD · Department of Dermatology, Charite-Universitätsmedizin, Berlin

Eligibility

Min Age
0 Hours
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-10-31
Completion
2007-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01131403 on ClinicalTrials.gov