Allergy, Contact Allergy, Dermatitis
Conditions
Brief summary
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
Interventions
DEVICENeoMatriX Collagen Dressing
Collagen wound dressing
Sponsors
NeXtGen Biologics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults; * Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement; * Subjects must be considered dependable and able to follow directions
Exclusion criteria
* Subjects who are in ill health; * Subjects who are taking medications other than birth control; * Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial; * Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials; * Subjects with any active skin disease; * Subjects who have heavy alcohol consumption; * Subjects with current use or history of repeated use of street drugs; * Subjects with a significant past medical history to potentially effect results of study; * Subjects with immunization less than 10 days prior to the test patch application;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema at the Patch Test Site is Evaluated for Each Participant | 3 weeks | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitization Reactions | 5 weeks | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a wash-out period). The patch test site will be tested on the same study subject population, but using a virgin test site. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collagen Dressing and Comparator NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.
NeoMatriX Collagen Dressing: Collagen wound dressing | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Collagen Dressing and Comparator | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 59 Participants | — |
| Age, Continuous | 46 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 68 participants | — |
| Sex: Female, Male Female | 44 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Erythema at the Patch Test Site is Evaluated for Each Participant
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NeoMatriX | Erythema at the Patch Test Site is Evaluated for Each Participant | 0.00 erythema score |
| Positive Control | Erythema at the Patch Test Site is Evaluated for Each Participant | 0.59 erythema score |
| Negative Control | Erythema at the Patch Test Site is Evaluated for Each Participant | 0.00 erythema score |
Secondary
Sensitization Reactions
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a wash-out period). The patch test site will be tested on the same study subject population, but using a virgin test site.
Time frame: 5 weeks
Population: Only the experimental material (NeoMatriX) was tested for potential sensitization reactions.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NeoMatriX | Sensitization Reactions | 0 erythema score |