Evaluation of Factors Affecting Diaper Dermatitis

Diaper Dermatitis Clinical Trial

Official title:

Evaluation of Factors Affecting Diaper Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04294186
• Other study ID #: EOFADD
• Status: Not yet recruiting
• Start date: April 18, 2020
• Est. completion date: April 18, 2020

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: hisham zn abd el haffez, ass.prof.
• Phone: 01223971409
• Email: hishamzayan[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• age <2 years whether male or female.

• having diaper dermatitis

Exclusion Criteria:

• age > 2 years .

Related Conditions & MeSH terms

• Dermatitis
• Diaper Dermatitis
• Diaper Rash

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Atherton DJ. Understanding irritant napkin dermatitis. Int J Dermatol. 2016 Jul;55 Suppl 1:7-9. doi: 10.1111/ijd.13334. Review. — View Citation

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. — View Citation

Carr AN, DeWitt T, Cork MJ, Eichenfield LF, Fölster-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. — View Citation

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. — View Citation

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. — View Citation

Singalavanija S, Frieden IJ. Diaper dermatitis. Pediatr Rev. 1995 Apr;16(4):142-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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