NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

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.

Study Overview

• Status: Completed
• Conditions: Allergy; Dermatitis, Allergic Contact; Allergy Skin
• Intervention / Treatment: Device: NeoMatriX Wound MatriX Collagen Dressing

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo Clinical and Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NeoMatriX and Two Comparators; NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)	Device: NeoMatriX Wound MatriX Collagen Dressing; Collagen wound dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	15 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 hrs
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).	2 days

Collaborators and Investigators

• Sponsor: NeXtGen Biologics, Inc.
• Collaborators: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): April 26, 2018
• Study Completion (Actual): April 28, 2018

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Hypersensitivity; Dermatitis; Dermatitis, Allergic Contact
• Other Study ID Numbers: CL-18002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not yet determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No