Diaper RashNCT02299206
CeraVe Cream Compared to Desitin Paste for Treating Diaper Dermatitis in Infants
A study testing CeraVe Baby Diaper Rash Cream and Desitin Maximum Strength Original Paste in people with Diaper Rash, run by Northwestern University at 3 sites in United States.
Trial summary
This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Diaper Rash
- What is being tested?
- CeraVe Baby Diaper Rash Cream and Desitin Maximum Strength Original Paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children (except for diaper dermatitis) between 3 and 18 months of age
- Wearing diapers 24 hours per day
- Clinical irritant diaper dermatitis
- Received a Diaper Dermatitis severity score of 1.0 to 2.0 by investigator at screening visit (mild-moderate severity)
- Parent/caregiver will not change type or brand of diaper during the study, although the diaper type will be recorded
- No alteration of current product usage for creams, lotions, ointments, powders, soap, laundry detergents, and fabric softeners
- A parent or guardian of minors must sign the approved Institutional Review Board consent form prior to the conduct of any study-related procedures
Who cannot join
- Illness within past 4 days before study enrollment or any medical condition that may affect risk of study participation
- Does not wear diapers 24 hours per day or currently being toilet trained
- Active diagnosis or history of dermatological conditions other than diaper rash that may affect study
- Concomitant use of medications that may affect study (e.g., antifungal, topical steroid, or topical calcineurin inhibitor)
- Previous allergic reaction or known sensitivity to ingredients in study agents
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2991
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
Lurie Children's Hospital Outpatient Clinic at Lincoln Park
Chicago, Illinois, 60614
About this study
Official title: Randomized, Double-Blind, Parallel Group, Non-Inferiority Clinical Trial of CeraVe Baby Diaper Rash Cream Compared to Desitin Maximum Strength Original Paste for Management of Diaper Dermatitis in Infants
This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups will administer the product with each diaper change throughout the course of the study period. Product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Subjects will be assessed by the study doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Read the detailed description
Visit 1 - Screening and Baseline Visit (Day 0) Subjects will be evaluated for study eligibility using inclusion and exclusion criteria. The study doctor will assess diaper dermatitis for inclusion and exclusion criteria and to verify mild to moderate severity. Once study eligibility has been confirmed, parental/guardian consent will be obtained. No washout period is necessary for this study.
Location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Study products will be dispensed to parent/caregiver, along with instructions for administration. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will be asked to complete the daily diary for each day of the study.
Visit 2 (Day 7) Subjects will again be assessed by the study doctor. Parent/caregiver will be asked about any adverse effects in last 7 days.
Visit 3 - End of study (Day 14) Subjects will again be assessed by the study doctor. Daily diaries and product will be collected at this time. Parent/caregiver will be asked about any adverse effects in last 7 days. Parents/caregivers will also be given a questionnaire rating the use of the study products.
- Conditions
- Diaper Rash
- Being tested
- CeraVe Baby Diaper Rash Cream, Desitin Maximum Strength Original Paste
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe Baby Diaper Rash CreamDrug
Also called CeraVe BDRC NDC Code: 0187-2221
Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
Desitin Maximum Strength Original PasteDrug
Also called Desitin MSOP NDC Code: 58232-0721
Parents/caregivers of subjects will administer Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| CeraVe Baby Diaper Rash Cream | Experimental | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. Receives: Drug: CeraVe Baby Diaper Rash Cream |
| Desitin Maximum Strength Original Paste | Experimental | Healthy 3-18 months old infants with mild to moderate diaper dermatitis. Receives: Drug: Desitin Maximum Strength Original Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
Measured: 14 days
Secondary outcomes (4)
Change in Physician Assessment Diaper Dermatitis Scores to Day 7
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
Measured: 7 days
Parents/Caregivers Daily Scores Through Duration of the Study Period
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
Measured: 14 days
Assessment of Tolerability by the Infant
Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level
Measured: 14 days
Parent/Caregiver Rating of Satisfaction With Use of the Product
Parents/caregivers will be given a questionnaire rating the use of the study products.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Principal Investigator and sponsor agreed to termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Department of Der,matology, Feinberg School of Medicine, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299206
- Sponsor's protocol ID
- ASP05012014
- Status last verified
- Feb 2018
- First submitted
- 20 Nov 2014
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Parallel Group, Non-Inferiority Clinical Trial of CeraVe Baby Diaper Rash Cream Compared to Desitin Maximum Strength Original Paste for Management of Diaper Dermatitis in Infants
- ClinicalTrials.gov ID
- NCT02299206
- Acronym / sponsor ID
- ASP05012014
- Conditions
- Diaper Rash
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator and sponsor agreed to termination.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Dec 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, 1:1 randomized, double-blind, parallel-group, non-inferiority controlled trial to demonstrate non-inferiority of CeraVe Baby Diaper Rash Cream compared to Desitin Maximum Strength Original Paste when administered to children with diaper dermatitis who are between 3 months to 18 months of age. Parents/caregivers of subjects in both groups will administer the product with each diaper change throughout the course of the study period. Product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. Subjects will be assessed by the study doctor, parent/caregiver will be asked about any adverse effects. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Detailed description
Visit 1 - Screening and Baseline Visit (Day 0) Subjects will be evaluated for study eligibility using inclusion and exclusion criteria. The study doctor will assess diaper dermatitis for inclusion and exclusion criteria and to verify mild to moderate severity. Once study eligibility has been confirmed, parental/guardian consent will be obtained. No washout period is necessary for this study.
Location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Study products will be dispensed to parent/caregiver, along with instructions for administration. Parent/caregivers will also be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level. Parents/caregivers will be asked to complete the daily diary for each day of the study.
Visit 2 (Day 7) Subjects will again be assessed by the study doctor. Parent/caregiver will be asked about any adverse effects in last 7 days.
Visit 3 - End of study (Day 14) Subjects will again be assessed by the study doctor. Daily diaries and product will be collected at this time. Parent/caregiver will be asked about any adverse effects in last 7 days. Parents/caregivers will also be given a questionnaire rating the use of the study products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CeraVe Baby Diaper Rash Cream | Experimental | Drug: CeraVe Baby Diaper Rash CreamHealthy 3-18 months old infants with mild to moderate diaper dermatitis. |
| Desitin Maximum Strength Original Paste | Experimental | Drug: Desitin Maximum Strength Original PasteHealthy 3-18 months old infants with mild to moderate diaper dermatitis. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy children (except for diaper dermatitis) between 3 and 18 months of age
- Wearing diapers 24 hours per day
- Clinical irritant diaper dermatitis
- Received a Diaper Dermatitis severity score of 1.0 to 2.0 by investigator at screening visit (mild-moderate severity)
- Parent/caregiver will not change type or brand of diaper during the study, although the diaper type will be recorded
Key exclusion criteria (5 listed)
- Illness within past 4 days before study enrollment or any medical condition that may affect risk of study participation
- Does not wear diapers 24 hours per day or currently being toilet trained
- Active diagnosis or history of dermatological conditions other than diaper rash that may affect study
- Concomitant use of medications that may affect study (e.g., antifungal, topical steroid, or topical calcineurin inhibitor)
- Previous allergic reaction or known sensitivity to ingredients in study agents
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 |
|---|---|---|
| CeraVe Baby Diaper Rash CreamAlso: CeraVe BDRC NDC Code: 0187-2221Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. | Drug | CeraVe Baby Diaper Rash Cream |
| Desitin Maximum Strength Original PasteAlso: Desitin MSOP NDC Code: 58232-0721Parents/caregivers of subjects will administer Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period. | Drug | Desitin Maximum Strength Original Paste |
Primary outcome
Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.
Time frame: 14 days
For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.
4 secondary outcomes
Change in Physician Assessment Diaper Dermatitis Scores to Day 7
Time frame: 7 days
Parents/Caregivers Daily Scores Through Duration of the Study Period
Time frame: 14 days
Assessment of Tolerability by the Infant
Time frame: 14 days
Parent/Caregiver Rating of Satisfaction With Use of the Product
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diaper Rash
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
Diaper Dermatitis
Recruiting
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.
Amy Paller, MD principal investigator
Department of Der,matology, Feinberg School of Medicine, Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraVe Baby Diaper Rash Cream and Desitin Maximum Strength Original Paste in people with Diaper Rash, run by Northwestern University at 3 sites in United States.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group. (time frame: 14 days). 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 13 Mar 2018; AzTrials last refreshed its copy on 26 Oct 2026.