Erythema, Transepidermal Water Loss
Conditions
Brief summary
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
Detailed description
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.
Interventions
DEVICETest Article
Omeza Collagen Matrix
Sponsors
Omeza, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal Water Loss (TEWL) | 24 hours | Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema | 24 hours | Irritancy Grading on a 0-4 scale |
Countries
United Kingdom
Outcome results
None listed