Human Repeated Insult Patch Test

NeXtGen Biologics

Status: Completed

Conditions: Contact Allergy; Dermatitis; Allergy

Treatments: Device: NeoMatriX Collagen Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03474874

NNAU01-001

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Collagen Dressing and Comparator

Other group

Description:

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

Treatment:

Device: NeoMatriX Collagen Dressing