Evaluation of Factors Affecting Diaper Dermatitis

March 2, 2020 updated by: norhan osama mohammed hassan, Assiut University

Diaper dermatitis is one of the most common skin problems in infants and children.It is a skin disorder in the perineal , perianal and surrounding area .It frequently occurs also in areas immediately adjacent to the diaper area .

Diaper dermatitis is caused by lack of fresh air,dampness and irritation.With prevelance from 7-35 % in newborns.This skin disorder typically develops between nine and twelve months of age .

Study Overview

Status

Unknown

Conditions

Detailed Description

The development of diaper dermatitis is multifactorial . Newborn skin exhibits a cutaneous immaturity and an increased susceptibility toward skin barrier disruption or percutaneous absorption.

The epidermal barrier function resides in the outermost epidermal layer , the stratum corneum , which is the region of terminal skin differnatiation and is composed of corneocytes . The hydrophobic components of the lipid matrix provide the epidermal permeability barrier and protect against excessive water loss and irritant penetration , whereas the corneocytes and the cornified envelope provide mechanical strength to the stratum corneum.

The skin in the diaper area is predisposed to irritation by the prolonged contact with irritants , such as urine and feces as well as by diaper occlusion, with leads to an increase in hydration and skin ph. Overhydration promotes degradation of "the brick and mortar" structure of stratum corneum, contributing to impraired barrier function.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the out patient clinic of department of dermatology,venereology and andrology , Assuit university .

Description

Inclusion Criteria:

  • age <2 years whether male or female.
  • having diaper dermatitis

Exclusion Criteria:

  • age > 2 years .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patients with risk factors for Diaper dermatitis
Time Frame: One week
The percentage of patients with breastfeeding, presence of diarrhea, and frequency of diaper change
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 18, 2020

Primary Completion (Anticipated)

April 18, 2020

Study Completion (Anticipated)

April 18, 2020

Study Registration Dates

First Submitted

February 22, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOFADD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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