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Principal Investigator left the Institution and decision was made by funders to terminate the trial.
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| Name | Class |
|---|---|
| Avadim Technologies, Inc. | INDUSTRY |
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Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several factors including: excessive moisture, topical irritants, reduced pH, friction, maceration and bacterial infection. When infants soil their diaper, diaper contents saturate the area raising the pH of the skin above the normal level of 5 or less, and leaving the area highly vulnerable to maceration from friction. Irritants in urine and feces are then able to penetrate the macerated skin, causing inflammation and greater skin friability. An elevation in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such, Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper rash wounds, as well as for assisting with wound healing and reducing any associated pain. The purpose of this study is to determine caregivers' perceptions of the benefits of using Theraworx Foam on their infant's diaper area as part of their hygienic routine, including whether they feel the product is pleasant and easy to use, and whether they feel it helps prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diaper care with Theraworx | Experimental | Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks. |
|
| Routine diaper care | No Intervention | Participants continue their typical diaper care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaper care with Theraworx | Drug | Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant | Caregivers self-report on a weekly basis the total number of days during the past week that their infant had a diaper rash. Diaper rash was defined as the presence of one or more of the following in the diaper region: redness, skin breakdown, papules or pustules. The total number of days with diaper rash for the entire 4 week period was summed from the 4 weekly surveys (outcome measure range: 0-28 days with fewer days representing a better outcome). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver's Self-report of Diaper Rash Severity | Caregivers used a modified Diaper Dermatitis Scale (Buckley, et al, Pediatric Dermatology 2016) to report infant diaper rash severity. The scale ranged from 0 (none) to 6 (most severe) with higher scores indicating a worse outcome. Items on the scale included assessments of rash size (0-2), redness (0-1), evidence of skin breakdown (0-1), evidence of papules (0-1) and evidence of pustules (0-1). Mean score was calculated using scores for every day over 28 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chidlren's National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
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All participants completed routine diaper care during the run-in period, followed by diaper care with Theraworx during the experimental period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Diaper Care Followed by Diaper Care With Theraworx | Participants continue their typical diaper care for a period of 4 weeks. This is directly followed by 4 weeks of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Routine Diaper Care |
| |||||||||||||
| Diaper Care With Theraworx |
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Diaper Care Followed by Diaper Care With Theraworx | Participants continue their typical diaper care for 4 weeks followed immediately by 4 weeks of using Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000). During this second period, particpants apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks. Diaper care with Theraworx: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Caregiver's Self-report of Prevention of Diaper Dermatitis in Infant | Caregivers self-report on a weekly basis the total number of days during the past week that their infant had a diaper rash. Diaper rash was defined as the presence of one or more of the following in the diaper region: redness, skin breakdown, papules or pustules. The total number of days with diaper rash for the entire 4 week period was summed from the 4 weekly surveys (outcome measure range: 0-28 days with fewer days representing a better outcome). | Posted | Mean | Standard Deviation | days | 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diaper Care With Theraworx | Participants will be given a 4 week supply of Theraworx Spray Foam, an FDA-registered OTC drug (NDC 61594-000), to apply a thin layer to their infant's entire diaper area with every diaper change (2-4 foam pumps or 4-6 sprays depending on the infant's size) for 4 weeks. Diaper care with Theraworx: Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elena Gibson | Children's Research Institute | (202) 476-6877 | egibson@cnmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2020 | Oct 6, 2021 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D015034 | Zinc Oxide |
| ID | Term |
|---|---|
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D007287 | Inorganic Chemicals |
| D017967 | Zinc Compounds |
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| 4 weeks |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Frequency of diaper rash in last 30 days, continuous | Median | Inter-Quartile Range | days |
|
|
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| Secondary | Caregiver's Self-report of Diaper Rash Severity | Caregivers used a modified Diaper Dermatitis Scale (Buckley, et al, Pediatric Dermatology 2016) to report infant diaper rash severity. The scale ranged from 0 (none) to 6 (most severe) with higher scores indicating a worse outcome. Items on the scale included assessments of rash size (0-2), redness (0-1), evidence of skin breakdown (0-1), evidence of papules (0-1) and evidence of pustules (0-1). Mean score was calculated using scores for every day over 28 days. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Routine Diaper Care | Participants continue their typical diaper care. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |