NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

NCT03522675 | Completed Results FDA Device

• 1 other identifier: CL-18002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy Skin; Allergy; Dermatitis, Allergic Contact

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Wheal Formation

  6 hrs

• Wheal Formation

  2 days

Study Arms (1)

NeoMatriX and Two Comparators

OTHER

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

Device: NeoMatriX Wound MatriX Collagen Dressing

Interventions

NeoMatriX Wound MatriX Collagen Dressing DEVICE

Collagen wound dressing

NeoMatriX and Two Comparators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeXtGen Biologics, Inc.: lead
• State University of New York at Buffalo: collaborator

Study Sites (1)

University at Buffalo Clinical and Translational Research Center

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Hypersensitivity; Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Immune System Diseases; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed

Results Point of Contact

• Title: Dayna Healy
• Organization: NeXtGen Biologics, Inc

Dhealy@nextgenbiologics.com

352-215-9961

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 11, 2018
• Study Start: April 11, 2018
• Primary Completion: April 26, 2018
• Study Completion: April 28, 2018
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Locations

US (1)