Diaper DermatitisNCT07186907
Hydrocolloid Dressings in Diaper Dermatitis
A study testing Hydrocolloid dressing and Zinc oxide cream %40 in people with Diaper Dermatitis and Diaper Dermatitis Healing, run by Gozde AKSUCU at 1 site in Turkey (Türkiye).
Trial summary
Diaper dermatitis (commonly known as diaper rash) is one of the most frequent skin problems in newborns and infants, especially in neonatal intensive care units (NICUs). This study was designed to compare two treatment approaches for diaper dermatitis: hydrocolloid dressings and a cream containing 40% zinc oxide. Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Diaper Dermatitis, Diaper Dermatitis Healing, Diaper Rash
- What is being tested?
- Hydrocolloid dressing and Zinc oxide cream %40
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2017to 17 Mar 2018
- Phase
- Interventional
- 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 0 days to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalization in the NICU
- Body weight greater than 1000 g at the start of the intervention
- Gestational age above 26 weeks
- Diaper dermatitis diagnosis confirmed by a clinician
- Clinically stable condition at enrollment
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Congenital skin anomalies
- Dermatitis due to other dermatological conditions
- Systemic bacterial or fungal infections
- Receiving immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, Bakırköy, 34140
About this study
Official title: Hydrocolloid Dressing for Diaper Dermatitis in NICU Hospitalized Neonates and Young Infants: A Quasi-Experimental Study
Diaper dermatitis (commonly known as diaper rash) is one of the most frequent skin problems in newborns and infants, especially in neonatal intensive care units (NICUs). This study was designed to compare two treatment approaches for diaper dermatitis: hydrocolloid dressings and a cream containing 40% zinc oxide. The severity of diaper rash was evaluated at the beginning of treatment and at 24, 48, and 72 hours of follow-up.
Read the detailed description
Diaper dermatitis (diaper rash) is a common skin problem in neonates and infants, often associated with prolonged exposure of the skin to moisture, urine, and stool. Infants hospitalized in neonatal intensive care units (NICUs) are particularly vulnerable due to frequent stools, immature skin, and exposure to irritants. This study was conducted to evaluate the effectiveness of hydrocolloid dressings compared with standard barrier cream containing 40% zinc oxide in the management of diaper dermatitis. A total of 44 infants hospitalized in a NICU and clinically diagnosed with diaper dermatitis were included. Infants were allocated into two groups: the intervention group received hydrocolloid dressings applied to the affected area, while the control group received zinc oxide cream. The severity of diaper dermatitis was assessed using a standardized clinical evaluation scale at baseline and at 24, 48, and 72 hours after initiation of the intervention. The primary aim was to compare changes in severity scores and healing time between the two treatment groups.
- Conditions
- Diaper Dermatitis, Diaper Dermatitis Healing, Diaper Rash
- Being tested
- Hydrocolloid dressing, Zinc oxide cream %40
- Keywords
- diaper dermatitis, hydrocolloid dressing, zinc oxide, NICU, quasi-experimental
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocolloid dressingDevice
Hydrocolloid dressing was used for diaper dermatitis
Zinc oxide cream %40Drug
Zinc oxide cream was used in diaper dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocolloid dressing | Experimental | Not described Receives: Device: Hydrocolloid dressing |
| Zinc oxide cream (Control group) | Active comparator | Not described Receives: Drug: Zinc oxide cream %40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaper dermatitis severity score
The severity of diaper dermatitis will be assessed using the Clinical Evaluation Scale for Characterization of the Severity of Diaper Dermatitis (Stamatas \& Tierney, 2014). Scores range from 0 (no dermatitis) to 3.0 (severe dermatitis), with 0.5-point increments. Higher scores indicate greater severity.
Measured: Baseline, 24 hours, 48 hours, and 72 hours after initiation of intervention.
Time to complete healing of diaper dermatitis
Complete healing is defined as a diaper dermatitis score of "0" on the Clinical Evaluation Scale. The proportion of infants achieving complete healing within 72 hours will be compared between groups.
Measured: Within 72 hours after initiation of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start13 Nov 2017
- Primary completion13 Mar 2018
- Study completion17 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gozde AKSUCU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gozde AKSUCU, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186907
- Sponsor's protocol ID
- 2017-15-12
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocolloid Dressing for Diaper Dermatitis in NICU Hospitalized Neonates and Young Infants: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07186907
- Acronym / sponsor ID
- 2017-15-12
- Conditions
- Diaper Dermatitis, Diaper Dermatitis Healing, Diaper Rash
- Keywords
- diaper dermatitis, hydrocolloid dressing, zinc oxide, NICU, quasi-experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gozde AKSUCUUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 17 Mar 2018 (actual)
- First posted
- 22 Sep 2025 (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 (commonly known as diaper rash) is one of the most frequent skin problems in newborns and infants, especially in neonatal intensive care units (NICUs). This study was designed to compare two treatment approaches for diaper dermatitis: hydrocolloid dressings and a cream containing 40% zinc oxide. The severity of diaper rash was evaluated at the beginning of treatment and at 24, 48, and 72 hours of follow-up.
Detailed description
Diaper dermatitis (diaper rash) is a common skin problem in neonates and infants, often associated with prolonged exposure of the skin to moisture, urine, and stool. Infants hospitalized in neonatal intensive care units (NICUs) are particularly vulnerable due to frequent stools, immature skin, and exposure to irritants. This study was conducted to evaluate the effectiveness of hydrocolloid dressings compared with standard barrier cream containing 40% zinc oxide in the management of diaper dermatitis. A total of 44 infants hospitalized in a NICU and clinically diagnosed with diaper dermatitis were included. Infants were allocated into two groups: the intervention group received hydrocolloid dressings applied to the affected area, while the control group received zinc oxide cream. The severity of diaper dermatitis was assessed using a standardized clinical evaluation scale at baseline and at 24, 48, and 72 hours after initiation of the intervention. The primary aim was to compare changes in severity scores and healing time between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocolloid dressing | Experimental | Device: Hydrocolloid dressing |
| Zinc oxide cream (Control group) | Active comparator | Drug: Zinc oxide cream %40 |
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Hospitalization in the NICU
- Body weight greater than 1000 g at the start of the intervention
- Gestational age above 26 weeks
- Diaper dermatitis diagnosis confirmed by a clinician
- Clinically stable condition at enrollment
Key exclusion criteria (4 listed)
- Congenital skin anomalies
- Dermatitis due to other dermatological conditions
- Systemic bacterial or fungal infections
- Receiving immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocolloid dressingHydrocolloid dressing was used for diaper dermatitis | Device | Hydrocolloid dressing |
| Zinc oxide cream %40Zinc oxide cream was used in diaper dermatitis. | Drug | Zinc oxide cream (Control group) |
Primary outcome
Change in diaper dermatitis severity score
Time frame: Baseline, 24 hours, 48 hours, and 72 hours after initiation of intervention.
The severity of diaper dermatitis will be assessed using the Clinical Evaluation Scale for Characterization of the Severity of Diaper Dermatitis (Stamatas \& Tierney, 2014). Scores range from 0 (no dermatitis) to 3.0 (severe dermatitis), with 0.5-point increments. Higher scores indicate greater severity.
Time to complete healing of diaper dermatitis
Time frame: Within 72 hours after initiation of intervention.
Complete healing is defined as a diaper dermatitis score of "0" on the Clinical Evaluation Scale. The proportion of infants achieving complete healing within 72 hours will be compared between groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes
Related trials for Diaper Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
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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
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocolloid dressing and Zinc oxide cream %40 in people with Diaper Dermatitis and Diaper Dermatitis Healing, run by Gozde AKSUCU at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diaper dermatitis severity score (time frame: Baseline, 24 hours, 48 hours, and 72 hours after initiation of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2025.