Last reviewed · How we verify
NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test
NA trial testing NeoMatriX Wound MatriX Collagen Dressing in Allergy Skin in 22 participants. Completed in 28 April 2018.
| Lead sponsor | NeXtGen Biologics, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 22 |
| Start date | 11 April 2018 |
| Primary completion | 26 April 2018 |
| Estimated completion | 28 April 2018 |
| Sites | 1 location across United States |
NeXtGen Biologics, Inc.
18 and older, any sex, with Allergy Skin or Allergy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| NeoMatriX Alone | .85 | 0 – 3.5 |
| Positive Control | 6.68 | 4.5 – 11 |
| Negative Control | .2 | 0 – 3 |
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).
| Group | Value | 95% CI |
|---|---|---|
| NeoMatriX Alone | 0 | 0 – 0 |
| Positive Control | 0.1 | 0 – 1 |
| Negative Control | 0 | 0 – 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| NeoMatriX Alone | 0 | 0 – 0 |
| Positive Control | 0 | 0 – 0 |
| Negative Control | 0 | 0 – 0 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03522675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing