Allergy, Allergy Skin, Dermatitis, Allergic Contact
Conditions
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.
Interventions
DEVICENeoMatriX Wound MatriX Collagen Dressing
Collagen wound dressing
Sponsors
State University of New York at Buffalo
NeXtGen Biologics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wheal Formation | 15 minutes | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wheal Formation | 6 hrs | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NeoMatriX and Two Comparators NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL)
NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-reactive to histamine | 1 |
| Overall Study | Screen fail | 1 |
Baseline characteristics
| Characteristic | NeoMatriX and Two Comparators |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 38.35 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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).
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NeoMatriX Alone | Wheal Formation | .85 mm |
| Positive Control | Wheal Formation | 6.68 mm |
| Negative Control | Wheal Formation | .2 mm |
Other Pre-specified
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).
Time frame: 6 hrs
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NeoMatriX Alone | Wheal Formation | 0 mm |
| Positive Control | Wheal Formation | 0.1 mm |
| Negative Control | Wheal Formation | 0 mm |
Other Pre-specified
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).
Time frame: 2 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NeoMatriX Alone | Wheal Formation | 0 mm |
| Positive Control | Wheal Formation | 0 mm |
| Negative Control | Wheal Formation | 0 mm |