NCT04294186

Brief Summary

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 18, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

Same day

First QC Date

February 22, 2020

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with risk factors for Diaper dermatitis

    The percentage of patients with breastfeeding, presence of diarrhea, and frequency of diaper change

    One week

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • age \> 2 years .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Gozen D, Caglar S, Bayraktar S, Atici F. Diaper dermatitis care of newborns human breast milk or barrier cream. J Clin Nurs. 2014 Feb;23(3-4):515-23. doi: 10.1111/jocn.12047. Epub 2013 Mar 19.

    PMID: 23506257BACKGROUND
  • Carr AN, DeWitt T, Cork MJ, Eichenfield LF, Folster-Holst R, Hohl D, Lane AT, Paller A, Pickering L, Taieb A, Cui TY, Xu ZG, Wang X, Brink S, Niu Y, Ogle J, Odio M, Gibb RD. Diaper dermatitis prevalence and severity: Global perspective on the impact of caregiver behavior. Pediatr Dermatol. 2020 Jan;37(1):130-136. doi: 10.1111/pde.14047. Epub 2019 Dec 2.

    PMID: 31793090BACKGROUND
  • Atherton DJ. Understanding irritant napkin dermatitis. Int J Dermatol. 2016 Jul;55 Suppl 1:7-9. doi: 10.1111/ijd.13334.

    PMID: 27311779BACKGROUND
  • Blume-Peytavi U, Kanti V. Prevention and treatment of diaper dermatitis. Pediatr Dermatol. 2018 Mar;35 Suppl 1:s19-s23. doi: 10.1111/pde.13495.

    PMID: 29596731BACKGROUND
  • Farahani LA, Ghobadzadeh M, Yousefi P. Comparison of the effect of human milk and topical hydrocortisone 1% on diaper dermatitis. Pediatr Dermatol. 2013 Nov-Dec;30(6):725-9. doi: 10.1111/pde.12118. Epub 2013 Apr 22.

  • Singalavanija S, Frieden IJ. Diaper dermatitis. Pediatr Rev. 1995 Apr;16(4):142-7. doi: 10.1542/pir.16-4-142. No abstract available.

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Central Study Contacts

hisham zn abd el haffez, ass.prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 22, 2020

First Posted

March 3, 2020

Study Start

April 18, 2020

Primary Completion

April 18, 2020

Study Completion

April 18, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03