NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Using a minimally invasive skin prick test, the test material, positive control, and negative control are applied to the forearm using a prick test. The test area is observed after 15 minutes, 6 hours, and again at 1-2 days after the initial prick test. The skin will be examined for a reaction such as a wheal and/or a flare, a flare alone is not clinically significant.

Inclusion criteria

• Healthy volunteers aged at least 18 years.
• Completed written informed consent and receive a copy of their executed ICF.
• Volunteers must be capable of understanding and following directions in English.

Exclusion criteria

• Pregnancy or lactation;
• Inadequate or non-existent contraception (women of child bearing potential only);
• A current skin disease;
• Heavy alcohol consumption;
• Current use or history of repeated use of recreational drugs;
• Recent illness prior to test;
• Significant past medical history of diseases to potentially effect study results;
• Current treatment of allergy;
• A history of multiple drug hypersensitivity;
• Concurrent medication likely to affect the response to the test articles or confuse the results of the study;
• Known sensitivity to the test articles;
• Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month;
• Sensitization or questionable sensitization in a skin test;
• Recent immunization.