Human Repeated Insult Patch Test

June 27, 2019 updated by: NeXtGen Biologics, Inc.
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Fairfield, New Jersey, United States, 07004
        • Consumer Product Testing Company, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: NeoMatriX Collagen 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

This is where you will find people and organizations involved with this study.

Sponsor

NeXtGen Biologics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

April 6, 2018

Study Completion (Actual)

April 6, 2018

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

May 1, 2019

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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