Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.
For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.
An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Article | Experimental | The test article was applied to an open application site and to a second site of induced inflammation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Article | Device | Omeza Collagen Matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss (TEWL) | Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury | 24 hours |
| Transepidermal Water Loss (TEWL) | Assessment of water evaporation (TWEL) based upon diffusion principle | 48 hours |
| Transepidermal Water Loss (TEWL) | Assessment of water evaporation (TWEL) based upon diffusion principle | 72 hours |
| Transepidermal Water Loss (TEWL) | Assessment of water evaporation (TWEL) based upon diffusion principle | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema | Irritancy Grading on a 0-4 scale | 24 hours |
| Erythema | Irritancy Grading on a 0-4 scale | 48 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barrie Drewitt | PCR Corp | Principal Investigator |
| Andrew King | PCR Corp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princeton Research Corporation | Chelmsford | Essex | CM2 6UA | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Erythema | Irritancy Grading on a 0-4 scale | 72 hours |
| Erythema | Irritancy Grading on a 0-4 scale | 96 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |