NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Not Applicable

Completed

• Conditions: Allergy Skin; Allergy; Dermatitis, Allergic Contact
• Interventions: Device: NeoMatriX Wound MatriX Collagen Dressing

• Registration Number: NCT03522675
• Lead Sponsor: NeXtGen Biologics, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-04-19
• Primary Completion: 2018-04-26
• Study Completion: 2018-04-28
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-11
• Results First Submitted: 2019-04-18
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-30
• Last Update Submitted: 2019-05-30
• Results First Posted: 2019-05-31
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeoMatriX and Two Comparators	NeoMatriX Wound MatriX Collagen Dressing	NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)

Primary Outcome Measures

Name	Time	Method
Wheal Formation	15 minutes	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).

Trial Locations

Locations (1)

University at Buffalo Clinical and Translational Research Center; 🇺🇸 Buffalo, New York, United States