NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test



Status:Completed
Conditions:Allergy, Allergy, Neurology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:April 11, 2018
End Date:April 28, 2018

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Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix

The objective of this study is to investigate the potential of NeoMatriXTM Wound Matrix to
cause an allergic response to healthy volunteers using a 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.
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