Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

Not Applicable

Completed

• Conditions: Erythema; Transepidermal Water Loss
• Interventions: Device: Test Article

• Registration Number: NCT04512274
• Lead Sponsor: Omeza, LLC

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-06-05
• Study Completion: 2020-06-05
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Article	Test Article	The test article was applied to an open application site and to a second site of induced inflammation

Primary Outcome Measures

Name	Time	Method
Transepidermal Water Loss (TEWL)	96 hours	Assessment of water evaporation (TWEL) based upon diffusion principle

Secondary Outcome Measures

Name	Time	Method
Erythema	96 hours	Irritancy Grading on a 0-4 scale

Trial Locations

Locations (1)

Princeton Research Corporation; 🇬🇧 Chelmsford, Essex, United Kingdom