Trials / Completed
CompletedNCT04510675
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
A 6-Week, Randomized, Evaluator-Blinded, In Vivo Within Subject Repeat Test to Evaluate the Irritation and Sensitization Potential of Omeza Collagen Matrix in Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Omeza, LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Test Article | Omeza Collagen Matrix |
| OTHER | Negative Control | Occlusive Patch of 0.9% sodium chloride, NaCl |
Timeline
- Start date
- 2019-12-02
- Primary completion
- 2020-01-11
- Completion
- 2020-01-11
- First posted
- 2020-08-12
- Last updated
- 2023-05-17
- Results posted
- 2023-05-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04510675. Inclusion in this directory is not an endorsement.