Back to resultsHuman Repeated Insult Patch Test
Primary Purpose
Dermatitis, Allergy, Contact Allergy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeoMatriX Collagen Dressing
Sponsored by
About this trial
This is an interventional other trial for Dermatitis
Eligibility Criteria
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;
Sites / Locations
- Consumer Product Testing Company, Inc.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Collagen Dressing and Comparator
Arm Description
NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03474874
Brief Title
Human Repeated Insult Patch Test
Official Title
Human Repeated Insult Patch Test
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
April 6, 2018 (Actual)
Study Completion Date
April 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeXtGen Biologics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Allergy, Contact Allergy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagen Dressing and Comparator
Arm Type
Other
Arm Description
NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.
Intervention Type
Device
Intervention Name(s)
NeoMatriX Collagen Dressing
Intervention Description
Collagen wound dressing
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Consumer Product Testing Company, Inc.
City
Fairfield
State/Province
New Jersey
ZIP/Postal Code
07004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Human Repeated Insult Patch Test
We'll reach out to this number within 24 hrs