NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

NeXtGen Biologics

Status

Completed

Conditions

Dermatitis, Allergic Contact

Allergy

Allergy Skin

Treatments

Device: NeoMatriX Wound MatriX Collagen Dressing

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03522675

CL-18002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.