Human Repeated Insult Patch Test

• Sponsor: NeXtGen Biologics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03474874
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 53.1

Study Details

Study Description

Brief Summary

Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin

Condition or Disease	Intervention/Treatment	Phase
Dermatitis; Allergy; Contact Allergy	Device: NeoMatriX Collagen Dressing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Human Repeated Insult Patch Test
• Actual Study Start Date: Feb 26, 2018
• Actual Primary Completion Date: Apr 6, 2018
• Actual Study Completion Date: Apr 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: NeoMatriX Collagen Dressing; Collagen wound dressing

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consumer Product Testing Company, Inc.	Fairfield	New Jersey	United States	07004

Sponsors and Collaborators

• NeXtGen Biologics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 13, 2018

More Information

Publications

None provided.

• Responsible Party: NeXtGen Biologics, Inc.
• ClinicalTrials.gov Identifier: NCT03474874
• Other Study ID Numbers: NNAU01-001
• First Posted: Mar 23, 2018
• Last Update Posted: Jul 16, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Allergic Contact; Hypersensitivity

Study Results

Participant Flow

Arm/Group Title	Collagen Dressing and Comparator
Arm/Group Description	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
Period Title: Overall Study
STARTED	68
COMPLETED	54
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Collagen Dressing and Comparator
Arm/Group Description	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 Participants	68
Age (Count of Participants)
<=18 years	1 1.5%
Between 18 and 65 years	59 86.8%
>=65 years	8 11.8%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	46
Sex: Female, Male (Count of Participants)
Female	44 64.7%
Male	24 35.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	68 100%

Outcome Measures

1. Primary Outcome

Title	Erythema at the Patch Test Site is Evaluated for Each Participant
Description	Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NeoMatriX	Positive Control	Negative Control
Arm/Group Description	NeoMatriX Collagen Dressing: Collagen wound dressing	0.4% SLS on absorbent pad of occlusive dressing	Normal saline on absorbent pad of occlusive dressing
Measure Participants	54	54	54
Mean (Full Range) [erythema score]	0.00	0.59	0.00

2. Secondary Outcome

Title	Sensitization Reactions
Description	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

Outcome Measure Data

Analysis Population Description

Only the experimental material (NeoMatriX) was tested for potential sensitization reactions.

Arm/Group Title	NeoMatriX	Positive Control	Negative Control
Arm/Group Description	NeoMatriX Collagen Dressing: Collagen wound dressing	0.4% SLS on absorbent pad of occlusive dressing	Normal saline on absorbent pad of occlusive dressing
Measure Participants	54	0	0
Mean (Full Range) [erythema score]	0

Adverse Events

Time Frame	40 days
Arm/Group Title	Collagen Dressing and Comparator
Arm/Group Description	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
All Cause Mortality
	Collagen Dressing and Comparator
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Serious Adverse Events
	Collagen Dressing and Comparator
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Other (Not Including Serious) Adverse Events
	Collagen Dressing and Comparator
	Affected / at Risk (%)	# Events
Total	0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.