This Study Evaluates Skin 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, and the Study is Intended to Evaluate Dermal Safety.
Purpose
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.
Condition
- Healthy Adult
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Healthy adult volunteers - Age 18 to 70 years - Able to comply with study procedures
Exclusion Criteria
- Use of medications that may interfere with skin test responses - Known allergy to personal care products or adhesives - History of autoimmune disease - History of cancer - Uncontrolled chronic medical conditions - History of dermatographism - Known allergy to study materials - Known hypersensitivity to study materials - Active dermatitis or eczema at the test site
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Skin Prick Test Procedure |
Participants will undergo a standardized skin prick test using a collagen-based material to evaluate local skin responses in healthy adult volunteers. |
|
Recruiting Locations
SerenaGroup Monroeville
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
More Details
- Status
- Recruiting
- Sponsor
- SerenaGroup, Inc.