Trial Outcomes & Findings for Human Repeated Insult Patch Test (NCT NCT03474874)

Results Overview

Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

3 weeks

Results posted on

2019-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	68
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collagen Dressing and Comparator n=68 Participants 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
Age, Categorical <=18 years	1 Participants n=68 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=68 Participants
Age, Categorical >=65 years	8 Participants n=68 Participants
Age, Continuous	46 years n=68 Participants
Sex: Female, Male Female	44 Participants n=68 Participants
Sex: Female, Male Male	24 Participants n=68 Participants
Region of Enrollment United States	68 participants n=68 Participants

PRIMARY outcome

Timeframe: 3 weeks

Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.

Outcome measures

Outcome measures
Measure	NeoMatriX n=54 Participants NeoMatriX Collagen Dressing: Collagen wound dressing	Positive Control n=54 Participants 0.4% SLS on absorbent pad of occlusive dressing	Negative Control n=54 Participants Normal saline on absorbent pad of occlusive dressing
Erythema at the Patch Test Site is Evaluated for Each Participant	0.00 erythema score Interval 0.0 to 0.0	0.59 erythema score Interval 0.0 to 1.0	0.00 erythema score Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: 5 weeks

Population: Only the experimental material (NeoMatriX) was tested for potential 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.

Outcome measures

Outcome measures
Measure	NeoMatriX n=54 Participants NeoMatriX Collagen Dressing: Collagen wound dressing	Positive Control 0.4% SLS on absorbent pad of occlusive dressing	Negative Control Normal saline on absorbent pad of occlusive dressing
Sensitization Reactions	0 erythema score Interval 0.0 to 0.0	—	—

Adverse Events

Collagen Dressing and Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dayna Healy

NeXtGen Biologics Inc

Phone: 352-215-9961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place