Allergy Clinical Trial
Official title:
Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix
NCT number | NCT03522675 |
Other study ID # | CL-18002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 11, 2018 |
Est. completion date | April 28, 2018 |
Verified date | May 2019 |
Source | NeXtGen Biologics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to investigate the potential of NeoMatriXTM Wound Matrix to cause an allergic response to healthy volunteers using a skin prick test.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 28, 2018 |
Est. primary completion date | April 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy volunteers aged at least 18 years. - Completed written informed consent and receive a copy of their executed ICF. - Volunteers must be capable of understanding and following directions in English. Exclusion Criteria: - Pregnancy or lactation; - Inadequate or non-existent contraception (women of child bearing potential only); - A current skin disease; - Heavy alcohol consumption; - Current use or history of repeated use of recreational drugs; - Recent illness prior to test; - Significant past medical history of diseases to potentially effect study results; - Current treatment of allergy; - A history of multiple drug hypersensitivity; - Concurrent medication likely to affect the response to the test articles or confuse the results of the study; - Known sensitivity to the test articles; - Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month; - Sensitization or questionable sensitization in a skin test; - Recent immunization. |
Country | Name | City | State |
---|---|---|---|
United States | University at Buffalo Clinical and Translational Research Center | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
NeXtGen Biologics, Inc. | State University of New York at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Wheal Formation | Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal >3 mm of the positive control (histamine). | 6 hrs | |
Other | Wheal Formation | Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal >3 mm of the positive control (histamine). | 2 days | |
Primary | Wheal Formation | Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal >3 mm of the positive control (histamine). | 15 minutes |
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