Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

Study Overview
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Brief Summary
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Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin

Detailed Description
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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.

Official Title
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A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin

Conditions
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Transepidermal Water Loss, Erythema

Intervention / Treatment
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* Device: Test Article


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a healthy male or female, aged 18 years or older. Subject has signed a written Informed Consent. Exclusion Criteria: Pregnancy or lactation. Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only). A current skin disease of any type at the test site (e.g. eczema, psoriasis) Heavy alcohol consumption in the opinion of the investigator. A fever in the last 12 hours, prior to the initial patch application. Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject. History of malignant disease. Insulin dependent or non-insulin dependent diabetes. Concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids). Known sensitivity to the treatment solutions or their constituents including patch materials. Sensitisation or questionable sensitisation in a Repeat Insult Patch Test. Use of self-tanning lotion on the test area, one week previous to the start of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Article<br>The test article was applied to an open application site and to a second site of induced inflammation | Device: Test Article<br>* Omeza Collagen Matrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema | Irritancy Grading on a 0-4 scale | 24 hours | 
| Erythema | Irritancy Grading on a 0-4 scale | 48 hours | 
| Erythema | Irritancy Grading on a 0-4 scale | 72 hours | 
| Erythema | Irritancy Grading on a 0-4 scale | 96 hours |