Diaper DermatitisNCT04294186
Evaluation of Factors Affecting Diaper Dermatitis
An observational study of Diaper Dermatitis, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Diaper Dermatitis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2020to 18 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: the out patient clinic of department of dermatology,venereology and andrology , Assuit university .
Who may be able to join
- age <2 years whether male or female.
- having diaper dermatitis
Who cannot join
- age > 2 years .
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Diaper Dermatitis
- Medical subject headings
- Diaper Rash
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with risk factors for Diaper dermatitis
The percentage of patients with breastfeeding, presence of diarrhea, and frequency of diaper change
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start18 Apr 2020 (estimated)
- Primary completion18 Apr 2020 (estimated)
- Study completion18 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, norhan osama mohammed hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294186
- Sponsor's protocol ID
- EOFADD
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 23506257Carr 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 31793090Atherton DJ. Understanding irritant napkin dermatitis. Int J Dermatol. 2016 Jul;55 Suppl 1:7-9. doi: 10.1111/ijd.13334.
PubMed 27311779Blume-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 29596731Farahani 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 23600719Singalavanija 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Affecting Diaper Dermatitis
- ClinicalTrials.gov ID
- NCT04294186
- Acronym / sponsor ID
- EOFADD
- Conditions
- Diaper Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Apr 2020 (estimated)
- Primary completion
- 18 Apr 2020 (estimated)
- Study completion
- 18 Apr 2020 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- the out patient clinic of department of dermatology,venereology and andrology , Assuit university .
Key inclusion criteria (2 listed)
- age <2 years whether male or female.
- having diaper dermatitis
Key exclusion criteria (1 listed)
- age > 2 years .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 23506257Gozen 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.
- Background: PubMed 31793090Carr 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.
- Background: PubMed 27311779Atherton DJ. Understanding irritant napkin dermatitis. Int J Dermatol. 2016 Jul;55 Suppl 1:7-9. doi: 10.1111/ijd.13334.
- Background: PubMed 29596731Blume-Peytavi U, Kanti V. Prevention and treatment of diaper dermatitis. Pediatr Dermatol. 2018 Mar;35 Suppl 1:s19-s23. doi: 10.1111/pde.13495.
- Results publication: PubMed 23600719Farahani 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.
- Results publication: PubMed 7731909Singalavanija S, Frieden IJ. Diaper dermatitis. Pediatr Rev. 1995 Apr;16(4):142-7. doi: 10.1542/pir.16-4-142. No abstract available.
Related trials for Diaper Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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Probiotics for Diaper Dermatitis
Diaper Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaper Dermatitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hisham zn abd el haffez, ass.prof. (01223971409 ext. 0882365030, hishamzayan@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with risk factors for Diaper dermatitis (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294186, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.