NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Completed · Not applicable

Conditions studied: Allergy Skin, Allergy, Dermatitis, Allergic Contact

In brief

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.

Key facts

Study ID

NCT03522675

Run by

NeXtGen Biologics, Inc.

People needed

22

Starts

2018-04-11

Expected to finish

2018-04-28

Last updated by the study team

2019-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University at Buffalo Clinical and Translational Research Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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