Human Repeated Insult Patch Test

Not Applicable

Completed

• Conditions: Dermatitis; Allergy; Contact Allergy
• Interventions: Device: NeoMatriX Collagen Dressing

• Registration Number: NCT03474874
• Lead Sponsor: NeXtGen Biologics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-26
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-23
• Primary Completion: 2018-04-06
• Study Completion: 2018-04-06
• Results First Submitted: 2019-04-19
• Results First Submitted QC: 2019-04-19
• Status Verified: 2019-05
• Results First Posted: 2019-05-10
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collagen Dressing and Comparator	NeoMatriX Collagen Dressing	NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.

Primary Outcome Measures

Name	Time	Method
Erythema at the Patch Test Site is Evaluated for Each Participant	3 weeks	Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.

Secondary Outcome Measures

Name	Time	Method
Sensitization Reactions	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.

Trial Locations

Locations (1)

Consumer Product Testing Company, Inc.; 🇺🇸 Fairfield, New Jersey, United States