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This study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Prick Test Procedure | Experimental | Participants will undergo a standardized skin prick test using a collagen-based material to evaluate local skin responses in healthy adult volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Matrix Skin Prick Test Device | Device | A collagen-based material applied during a standardized skin prick test procedure to assess local skin responses in healthy adult participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Prick Test Wheal Diameter | Allergic skin response will be assessed using a standardized skin prick test procedure. The reaction will be quantified by measuring the mean wheal diameter at the test site in millimeters (mm). | 15 minutes, ~6 hours (±30 minutes), and 24-48 hours after SPT administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SerenaGroup Monroeville | Monroeville | Pennsylvania | 15146 | United States |
The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.
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