N/A
Completed N=22
NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test
Allergy Skin · allergy · Dermatitis, Allergic Contact
Source: ClinicalTrials.gov NCT03522675 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Wheal Formation — .85; 6.68; .2 mm
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wheal Formation |
0; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03522675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.