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NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Primary Purpose

Allergy Skin, Allergy, Dermatitis, Allergic Contact

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeoMatriX Wound MatriX Collagen Dressing
Sponsored by
NeXtGen Biologics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allergy Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University at Buffalo Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NeoMatriX and Two Comparators

Arm Description

NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 19, 2018
Last Updated
May 30, 2019
Sponsor
NeXtGen Biologics, Inc.
Collaborators
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03522675
Brief Title
NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test
Official Title
Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
April 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeXtGen Biologics, Inc.
Collaborators
State University of New York at Buffalo

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy Skin, Allergy, Dermatitis, Allergic Contact

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NeoMatriX and Two Comparators
Arm Type
Other
Arm Description
NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)
Intervention Type
Device
Intervention Name(s)
NeoMatriX Wound MatriX Collagen Dressing
Intervention Description
Collagen wound dressing
Primary Outcome Measure Information:
Title
Wheal Formation
Description
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
Other Pre-specified Outcome Measures:
Title
Wheal Formation
Description
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
6 hrs
Title
Wheal Formation
Description
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
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University at Buffalo Clinical and Translational Research Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet determined

Learn more about this trial

NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

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