NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

NeXtGen Biologics, Inc.22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Allergy Skin Allergy Dermatitis, Allergic Contact

Interventions

NeoMatriX Wound MatriX Collagen DressingDEVICE

Collagen wound dressing

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University at Buffalo Clinical and Translational Research Center

Buffalo, New York, United States

Outcomes

Primary Outcomes

Wheal Formation

Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal \>3 mm of the positive control (histamine).

Time frame: 15 minutes

Data from ClinicalTrials.gov

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