Human Repeated Insult Patch Test

NCT03474874 | Completed Results FDA Device

• 1 other identifier: NNAU01-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (1)

• Sensitization Reactions

  5 weeks

Study Arms (1)

Collagen Dressing and Comparator

OTHER

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

Interventions

NeoMatriX Collagen Dressing DEVICE

Collagen wound dressing

Collagen Dressing and Comparator

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• NeXtGen Biologics, Inc.: lead

Study Sites (1)

Consumer Product Testing Company, Inc.

Fairfield, New Jersey, 07004, United States

Location

MeSH Terms

Conditions

Dermatitis; Hypersensitivity; Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Dermatitis, Contact; Skin Diseases, Eczematous; Hypersensitivity, Delayed

Results Point of Contact

• Title: Dayna Healy
• Organization: NeXtGen Biologics Inc

Dhealy@nextgenbiologics.com

352-215-9961

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 23, 2018
• Study Start: February 26, 2018
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: July 16, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-05

Locations

US (1)