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Status unknownNCT04294186Updated Mar 3, 2020

Evaluation of Factors Affecting Diaper Dermatitis

An observational study in Diaper Dermatitis, sponsored by Assiut University. Status unknown. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Ages
Up to 2 Years
Sex
All
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Study 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 .

Read the 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.

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Conditions studied

  • Diaper Dermatitis
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In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 232 observational studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age > 2 years .
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

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

    Time frame: One week

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 23506257 ↗
  • 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. PubMed 31793090 ↗
  • Atherton DJ. Understanding irritant napkin dermatitis. Int J Dermatol. 2016 Jul;55 Suppl 1:7-9. doi: 10.1111/ijd.13334. PubMed 27311779 ↗
  • 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. PubMed 29596731 ↗
  • 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. PubMed 23600719 ↗
  • Singalavanija S, Frieden IJ. Diaper dermatitis. Pediatr Rev. 1995 Apr;16(4):142-7. doi: 10.1542/pir.16-4-142. No abstract available. PubMed 7731909 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04294186
Lead sponsor
Assiut University
Responsible party
norhan osama mohammed hassan (principle investigator, Assiut University) — Principal investigator
First posted
Mar 3, 2020
Start date
Apr 18, 2020 (estimated)
Primary completion
Apr 18, 2020 (estimated)
Completion
Apr 18, 2020 (estimated)
Last update
Mar 3, 2020

Study contacts

hisham zn abd el haffez, ass.prof.
Contact
hishamzayan@icloud.com
01223971409 ext. 0882365030

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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