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This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Repeat Insult Patch Test Procedure | Experimental | Participants will undergo repeated occlusive patch applications of a collagen-based material to assess skin irritation and sensitization in healthy adult volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen-Based Material | Device | A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale | Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4). | During the induction phase (approximately 3 consecutive weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Allergic Contact Sensitization Response Using ICDRG Scale | Allergic contact sensitization response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4) following challenge exposure | Through completion of all skin assessments during the study (approximately 5-6 weeks) |
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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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