Human Repeated Insult Patch Test

Allergy Clinical Trial

Official title:

Human Repeated Insult Patch Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474874
• Other study ID #: NNAU01-001
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: April 6, 2018

Study information

• Verified date: May 2019
• Source: NeXtGen Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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;

Related Conditions & MeSH terms

• Allergy
• Contact Allergy
• Dermatitis
• Dermatitis, Allergic Contact
• Hypersensitivity

Intervention

Device:
• NeoMatriX Collagen Dressing
Collagen wound dressing

Locations

Country	Name	City	State
United States	Consumer Product Testing Company, Inc.	Fairfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NeXtGen Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitization Reactions	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