NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Allergy Clinical Trial

Official title:

Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522675
• Other study ID #: CL-18002
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Allergy
• Allergy Skin
• Dermatitis
• Dermatitis, Allergic Contact
• Hypersensitivity

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