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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03522675
Other study ID # CL-18002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 11, 2018
Est. completion date April 28, 2018

Study information

Verified date May 2019
Source NeXtGen Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date April 28, 2018
Est. primary completion date April 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
NeoMatriX Wound MatriX Collagen Dressing
Collagen wound dressing

Locations

Country Name City State
United States University at Buffalo Clinical and Translational Research Center Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
NeXtGen Biologics, Inc. State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Primary 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
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