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| Name | Class |
|---|---|
| Calmoseptine, Inc. | INDUSTRY |
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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.
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 Each participant has one week total participation, unless withdrawn.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calmoseptine Ointment | Active Comparator | Calmoseptine Ointment as part of a structured skin care regimen. |
|
| Destin Maximum Strength 40% Zinc | Active Comparator | Destin Maximum Strength 40% Zinc as part of a structured skin care regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calmoseptine Ointment | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed on Final day of data collection (Day 6) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Size of area affected by diaper dermatitis on Days 0-6. | The area will be calculated by multiplying the longest portion of the affected area measured in a head to toe orientation by the widest portion of the affected area measured from side to side (in centimeters). | Measured on Day 0, 1, 2, 3, 4, 5, and 6 |
| Adverse Events. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacinto Blas Mantaring, MD | Department of Pediatrics, Philippine General Hospital UP Manila | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philippine General Hospital - University of the Philippines, Manila | Manila | National Capital Region | 1000 | Philippines |
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| ID | Term |
|---|---|
| D003963 | Diaper Rash |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Destin Maximum Strength 40% Zinc | Drug | 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:
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| Assessed on Day 0, 1, 2, 3, 4, 5, and 6 |
Non-Serious and serious adverse events judged by physicians to be due to trial participation. |
| Recorder on Day 0, 1, 2, 3, 4, 5, and 6 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D008670 |
| Metals |