Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

NCT04512274 | Completed FDA Device

• 1 other identifier: OMZIFL3M
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transepidermal Water Loss; Erythema

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Erythema

  24 hours

• Erythema

  48 hours

• Erythema

  72 hours

• Erythema

  96 hours

Study Arms (1)

Test Article

EXPERIMENTAL

The test article was applied to an open application site and to a second site of induced inflammation

Device: Test Article

Interventions

Test Article DEVICE

Omeza Collagen Matrix

Test Article

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a healthy male or female, aged 18 years or older.
• Subject has signed a written Informed Consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (1)

Princeton Research Corporation

Chelmsford, Essex, CM2 6UA, United Kingdom

Location

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barrie Drewitt

  PCR Corp

  PRINCIPAL INVESTIGATOR

• Andrew King

  PCR Corp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: June 1, 2020
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)