- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03474874
Human Repeated Insult Patch Test
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Fairfield, New Jersey, United States, 07004
- Consumer Product Testing Company, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Collagen wound dressing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema at the Patch Test Site is Evaluated for Each Participant
Time Frame: 3 weeks
|
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitization Reactions
Time Frame: 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. |
5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNAU01-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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