Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

Erythema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512274
• Other study ID #: OMZIFL3M
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 5, 2020

Study information

• Verified date: September 2022
• Source: Omeza, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythema
• Transepidermal Water Loss

Intervention

Device:
• Test Article
Omeza Collagen Matrix

Locations

Country	Name	City	State
United Kingdom	Princeton Research Corporation	Chelmsford	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Omeza, LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal Water Loss (TEWL)	Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury	24 hours
Primary	Transepidermal Water Loss (TEWL)	Assessment of water evaporation (TWEL) based upon diffusion principle	48 hours
Primary	Transepidermal Water Loss (TEWL)	Assessment of water evaporation (TWEL) based upon diffusion principle	72 hours
Primary	Transepidermal Water Loss (TEWL)	Assessment of water evaporation (TWEL) based upon diffusion principle	96 hours
Secondary	Erythema	Irritancy Grading on a 0-4 scale	24 hours
Secondary	Erythema	Irritancy Grading on a 0-4 scale	48 hours
Secondary	Erythema	Irritancy Grading on a 0-4 scale	72 hours
Secondary	Erythema	Irritancy Grading on a 0-4 scale	96 hours