Human Repeated Insult Patch Test

NCT ID: NCT03474874

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2018-04-06

Brief Summary

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

Conditions

Dermatitis; Allergy; Contact Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

NeoMatriX Collagen Dressing

Intervention Type: DEVICE

Collagen wound dressing

Interventions

NeoMatriX Collagen Dressing

Collagen wound dressing

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NeXtGen Biologics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NNAU01-001

Identifier Type: -

Identifier Source: org_study_id