Status:
COMPLETED
Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
Lead Sponsor:
Omeza, LLC
Conditions:
Transepidermal Water Loss
Erythema
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- Subject is a healthy male or female, aged 18 years or older.
- Subject has signed a written Informed Consent.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04512274
Start Date
June 1 2020
End Date
June 5 2020
Last Update
September 30 2022
Active Locations (1)
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1
Princeton Research Corporation
Chelmsford, Essex, United Kingdom, CM2 6UA