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NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

NCT ID: NCT03522675

Last Updated: 2019-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2018-04-28

Brief Summary

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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

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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.

Conditions

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Allergy Skin Allergy Dermatitis, Allergic Contact

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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NeoMatriX and Two Comparators

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

Group Type OTHER

NeoMatriX Wound MatriX Collagen Dressing

Intervention Type DEVICE

Collagen wound dressing

Interventions

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NeoMatriX Wound MatriX Collagen Dressing

Collagen wound dressing

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role collaborator

NeXtGen Biologics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University at Buffalo Clinical and Translational Research Center

Buffalo, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CL-18002

Identifier Type: -

Identifier Source: org_study_id