Back to resultsSkin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
Primary Purpose
Transepidermal Water Loss, Erythema
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Test Article
Sponsored by
About this trial
This is an interventional basic science trial for Transepidermal Water Loss
Eligibility Criteria
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.
Sites / Locations
- Princeton Research Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test Article
Arm Description
The test article was applied to an open application site and to a second site of induced inflammation
Outcomes
Primary Outcome Measures
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Secondary Outcome Measures
Erythema
Irritancy Grading on a 0-4 scale
Erythema
Irritancy Grading on a 0-4 scale
Erythema
Irritancy Grading on a 0-4 scale
Erythema
Irritancy Grading on a 0-4 scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04512274
Brief Title
Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 5, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omeza, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transepidermal Water Loss, Erythema
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Article
Arm Type
Experimental
Arm Description
The test article was applied to an open application site and to a second site of induced inflammation
Intervention Type
Device
Intervention Name(s)
Test Article
Intervention Description
Omeza Collagen Matrix
Primary Outcome Measure Information:
Title
Transepidermal Water Loss (TEWL)
Description
Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury
Time Frame
24 hours
Title
Transepidermal Water Loss (TEWL)
Description
Assessment of water evaporation (TWEL) based upon diffusion principle
Time Frame
48 hours
Title
Transepidermal Water Loss (TEWL)
Description
Assessment of water evaporation (TWEL) based upon diffusion principle
Time Frame
72 hours
Title
Transepidermal Water Loss (TEWL)
Description
Assessment of water evaporation (TWEL) based upon diffusion principle
Time Frame
96 hours
Secondary Outcome Measure Information:
Title
Erythema
Description
Irritancy Grading on a 0-4 scale
Time Frame
24 hours
Title
Erythema
Description
Irritancy Grading on a 0-4 scale
Time Frame
48 hours
Title
Erythema
Description
Irritancy Grading on a 0-4 scale
Time Frame
72 hours
Title
Erythema
Description
Irritancy Grading on a 0-4 scale
Time Frame
96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barrie Drewitt
Organizational Affiliation
PCR Corp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew King
Organizational Affiliation
PCR Corp
Official's Role
Study Director
Facility Information:
Facility Name
Princeton Research Corporation
City
Chelmsford
State/Province
Essex
ZIP/Postal Code
CM2 6UA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
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