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Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Dressing and Comparator | Other | NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoMatriX Collagen Dressing | Device | Collagen wound dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Erythema at the Patch Test Site is Evaluated for Each Participant | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitization Reactions | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a "wash-out period"). The patch test site will be tested on the same study subject population, but using a virgin test site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consumer Product Testing Company, Inc. | Fairfield | New Jersey | 07004 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Collagen Dressing and Comparator | NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing. NeoMatriX Collagen Dressing: Collagen wound dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Collagen Dressing and Comparator | NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing. NeoMatriX Collagen Dressing: Collagen wound dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Erythema at the Patch Test Site is Evaluated for Each Participant | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. | Posted | Mean | Full Range | erythema score | 3 weeks |
|
40 days
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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 | Collagen Dressing and Comparator | NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing. NeoMatriX Collagen Dressing: Collagen wound dressing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dayna Healy | NeXtGen Biologics Inc | 352-215-9961 | Dhealy@nextgenbiologics.com |
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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 | Feb 13, 2018 | May 16, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D006967 | Hypersensitivity |
| D017449 | Dermatitis, Allergic Contact |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D003877 | Dermatitis, Contact |
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| 5 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Sensitization Reactions | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a "wash-out period"). The patch test site will be tested on the same study subject population, but using a virgin test site. | Only the experimental material (NeoMatriX) was tested for potential sensitization reactions. | Posted | Mean | Full Range | erythema score | 5 weeks |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
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| D017443 | Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |