Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

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

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

Study Overview

• Status: Completed
• Conditions: Erythema; Transepidermal Water Loss
• Intervention / Treatment: Device: Test Article

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Chelmsford, Essex, United Kingdom, CM2 6UA
      • Princeton Research Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Article; The test article was applied to an open application site and to a second site of induced inflammation	Device: Test Article; Omeza Collagen Matrix

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Omeza, LLC
• Investigators: Principal Investigator: Barrie Drewitt, PCR Corp; Study Director: Andrew King, PCR Corp

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): June 5, 2020
• Study Completion (ACTUAL): June 5, 2020

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: OMZIFL3M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes