Diaper DermatitisPhase 4NCT02716415
Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
A Phase 4 study testing Calmoseptine Ointment and Destin Maximum Strength 40% Zinc in people with Diaper Dermatitis, run by University of the Philippines at 1 site in Philippines.
Trial summary
The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Diaper Dermatitis
- What is being tested?
- Calmoseptine Ointment and Destin Maximum Strength 40% Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 sitePhilippines
- Study dates
- Mar 2015to 31 Mar 2018
- Phase
- Phase 4
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child participant must be < 1 year of age.
- The participant must, upon clinical inspection by an investigator, be assessed to have diaper dermatitis ≥ Grade 2 according to the study's diaper dermatitis severity scale (see "Primary Outcome").
- The participant's parent, next of kin or legally acceptable representative agrees to the child's inclusion and signs the informed consent.
- The participant's primary physician agrees to inclusion.
- There is a reasonable expectation that the participant will be hospitalized for at least 7 days and will be able to complete the study. (NB Study Participant Withdrawal Criteria b - Any participants discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study. Study participation will not under any circumstances lead to delay in a participant's discharge from hospital.)
- Participant has no known allergy or history of adverse reaction to any of the ingredients in either product or to any topical preparations or skin care products
Who cannot join
- Participants with a pre-existing full thickness wound within the study area.
- Participants with pre-existing active dermatological condition(s), other than DD, which may affect healing or interpretation of trial results. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist.
- Participant has a history of recurrent dermatological conditions, other than DD, that may imply difficult healing or affect interpretation of trial results.
- Participant has any severe acute or chronic medical condition such that trial participation may constitute a risk, or may interfere with their medical care, or affect interpretation of results, or their attending physician advises against participation.
- Participant is on systemic antifungal treatment (eg. Amphotericin B or Fluconazole), topical antifungal treatment and / or systemic or topical corticosteroids.
- Participant has in the preceding week been treated with topical agents that may affect healing (e.g. dimethicone based ointments, zinc oxide powder, petroleum jelly)
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital - University of the Philippines, Manila
Manila, National Capital Region, 1000
About this study
Official title: Randomized Controlled Trial Comparing the Efficacy and Safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.
Read the detailed description
This is a single-center, randomized, controlled, assessor-blinded clinical trial. Neonates born in UP-PGH or infants (< 1 year of age) in the general pediatric wards for any condition who have diaper dermatitis are recruited and randomized to treatment with either Calmoseptine Ointment or Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste as part of a structured skin care regimen. Each participant has one week total participation, unless withdrawn. Baseline data are collected and study treatment initiated on study entry day. Treatment continued and follow up data collected on six subsequent follow up days. Primary outcome: healing of Diaper Dermatitis after six days of treatment, defined as a Diaper Dermatitis Severity Score of zero attributed by blinded assessment. Secondary outcomes: Diaper Dermatitis Severity Score at each day of treatment; size of affected area; incidence of Candida infection; adverse events.
Zinc Oxide Ointment preparations including Calmoseptine Ointment and Desitin Maximum Strength 40% Diaper Rash Paste have been used to treat diaper dermatitis for many years around the world. There are no known reported hypersensitivities to either product and no reported serious adverse events. As the proposed study is in neonates and infants, as a precaution the evidence relating to the safety and toxicity of individual ingredients were reviewed for the trial protocol prior to commencement.
- Conditions
- Diaper Dermatitis
- Being tested
- Calmoseptine Ointment, Destin Maximum Strength 40% Zinc
- Keywords
- neonates, infants
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calmoseptine OintmentDrug
Also called Calmoseptine
A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered.
The regimen includes:
- regular diaper changing,
- gentle cleansing
- application of the trial ointment
Destin Maximum Strength 40% ZincDrug
Also called Destin
A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered.
The regimen includes:
- regular diaper changing,
- gentle cleansing
- application of the trial ointment
| Study group | Role | What they receive |
|---|---|---|
| Calmoseptine Ointment | Active comparator | Calmoseptine Ointment as part of a structured skin care regimen. Receives: Drug: Calmoseptine Ointment |
| Destin Maximum Strength 40% Zinc | Active comparator | Destin Maximum Strength 40% Zinc as part of a structured skin care regimen. Receives: Drug: Destin Maximum Strength 40% Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of diaper Dermatitis
Complete healing of Diaper Dermatitis on final study day, as determined by Diaper Dermatitis Severity Scale. Possible score range from zero (0 - clear skin) ti six (6 - severe erythema, all or most of the diaper area affected, with papules and/or pustules, and open skin affecting the dermis). Complete healing is defined as a Diaper Dermatitis Severity Score of zero (0).
Assessment of the primary outcome used in final analyses will be blinded. For determination of final trial results for the primary outcome, sets of high definition photographs for each patient on each treatment day will be assessed by independent wound, Ostomy and Continence Nursing Certification Board (WOCNB) certified wound care expert assessors based in the USA, who are blinded to treatment allocation, not involved in the study.
Measured: Assessed on Final day of data collection (Day 6)
Secondary outcomes (1)
Daily Diaper Dermatitis Severity Score
Diaper dermatitis severity, assessed as per primary outcome.
The size of area affected by diaper dermatitis is measured and recorded at baseline (study entry on Day 0) and on each follow up day (Days 1-6). Disposable paper tape measures are used to prevent cross-infection. Where more than one non-contiguous area is affected, each will be measured as described and added together. As the study will include neonates and infants up to one year of age, body size will differ significantly so that an affected area of a similar size may be more serious in one participant than in another. Accordingly, the mean body size and/or weight of treatment groups will be considered and the expression of area affected used in final analyses will be adjusted appropriately.
Measured: Assessed on Day 0, 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2015
- Primary completion31 Mar 2018
- Study completion31 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Calmoseptine, Inc.
- Responsible party
- Sponsor
- Investigators
- Jacinto Blas Mantaring, MD, Principal investigator, Department of Pediatrics, Philippine General Hospital UP Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716415
- Sponsor's protocol ID
- 2015-019-01
- Status last verified
- Apr 2020
- First submitted
- 24 Feb 2016
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Efficacy and Safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
- ClinicalTrials.gov ID
- NCT02716415
- Acronym / sponsor ID
- 2015-019-01
- Conditions
- Diaper Dermatitis
- Keywords
- neonates, infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Calmoseptine, Inc.
- Study start
- Mar 2015
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 23 Mar 2016 (estimated)
- 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.
The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.
Detailed description
This is a single-center, randomized, controlled, assessor-blinded clinical trial. Neonates born in UP-PGH or infants (< 1 year of age) in the general pediatric wards for any condition who have diaper dermatitis are recruited and randomized to treatment with either Calmoseptine Ointment or Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste as part of a structured skin care regimen. Each participant has one week total participation, unless withdrawn. Baseline data are collected and study treatment initiated on study entry day. Treatment continued and follow up data collected on six subsequent follow up days. Primary outcome: healing of Diaper Dermatitis after six days of treatment, defined as a Diaper Dermatitis Severity Score of zero attributed by blinded assessment. Secondary outcomes: Diaper Dermatitis Severity Score at each day of treatment; size of affected area; incidence of Candida infection; adverse events.
Zinc Oxide Ointment preparations including Calmoseptine Ointment and Desitin Maximum Strength 40% Diaper Rash Paste have been used to treat diaper dermatitis for many years around the world. There are no known reported hypersensitivities to either product and no reported serious adverse events. As the proposed study is in neonates and infants, as a precaution the evidence relating to the safety and toxicity of individual ingredients were reviewed for the trial protocol prior to commencement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calmoseptine Ointment | Active comparator | Drug: Calmoseptine OintmentCalmoseptine Ointment as part of a structured skin care regimen. |
| Destin Maximum Strength 40% Zinc | Active comparator | Drug: Destin Maximum Strength 40% ZincDestin Maximum Strength 40% Zinc as part of a structured skin care regimen. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The child participant must be < 1 year of age.
- The participant must, upon clinical inspection by an investigator, be assessed to have diaper dermatitis ≥ Grade 2 according to the study's diaper dermatitis severity scale (see "Primary Outcome").
- The participant's parent, next of kin or legally acceptable representative agrees to the child's inclusion and signs the informed consent.
- The participant's primary physician agrees to inclusion.
- There is a reasonable expectation that the participant will be hospitalized for at least 7 days and will be able to complete the study. (NB Study Participant Withdrawal Criteria b - Any participants discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study. Study participation will not under any circumstances lead to delay in a participant's discharge from hospital.)
Key exclusion criteria (6 listed)
- Participants with a pre-existing full thickness wound within the study area.
- Participants with pre-existing active dermatological condition(s), other than DD, which may affect healing or interpretation of trial results. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist.
- Participant has a history of recurrent dermatological conditions, other than DD, that may imply difficult healing or affect interpretation of trial results.
- Participant has any severe acute or chronic medical condition such that trial participation may constitute a risk, or may interfere with their medical care, or affect interpretation of results, or their attending physician advises against participation.
- Participant is on systemic antifungal treatment (eg. Amphotericin B or Fluconazole), topical antifungal treatment and / or systemic or topical corticosteroids.
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 |
|---|---|---|
| Calmoseptine OintmentAlso: CalmoseptineA full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered. The regimen includes: * regular diaper changing, * gentle cleansing * application of the trial ointment | Drug | Calmoseptine Ointment |
| Destin Maximum Strength 40% ZincAlso: DestinA full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered. The regimen includes: * regular diaper changing, * gentle cleansing * application of the trial ointment | Drug | Destin Maximum Strength 40% Zinc |
Primary outcome
Healing of diaper Dermatitis
Time frame: Assessed on Final day of data collection (Day 6)
Complete healing of Diaper Dermatitis on final study day, as determined by Diaper Dermatitis Severity Scale. Possible score range from zero (0 - clear skin) ti six (6 - severe erythema, all or most of the diaper area affected, with papules and/or pustules, and open skin affecting the dermis). Complete healing is defined as a Diaper Dermatitis Severity Score of zero (0). Assessment of the primary outcome used in final analyses will be blinded. For determination of final trial results for the primary outcome, sets of high definition photographs for each patient on each treatment day will be assessed by independent wound, Ostomy and Continence Nursing Certification Board (WOCNB) certified wound care expert assessors based in the USA, who are blinded to treatment allocation, not involved in the study.
1 secondary outcome
Daily Diaper Dermatitis Severity Score
Time frame: Assessed on Day 0, 1, 2, 3, 4, 5, and 6
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 24 Apr 2020.
- Individual participant dataSharing planned: No
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.
Jacinto Blas Mantaring, MD principal investigator
Department of Pediatrics, Philippine General Hospital UP Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calmoseptine Ointment and Destin Maximum Strength 40% Zinc in people with Diaper Dermatitis, run by University of the Philippines at 1 site in Philippines.
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 6 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 24 Apr 2020. 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 Philippines. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Healing of diaper Dermatitis (time frame: Assessed on Final day of data collection (Day 6)). 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 24 Apr 2020.