Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

• Sponsor: Omeza, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04512274
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Days): 4
• Patients Per Site Per Month: 167.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transepidermal Water Loss; Erythema	Device: Test Article	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jun 5, 2020
• Actual Study Completion Date: Jun 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Article	Device: Test Article; Omeza Collagen Matrix
No Intervention: Negative Control

Outcome Measures

Primary Outcome Measures

1. Transepidermal Water Loss (TEWL) [24 hours]

   Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury

2. Transepidermal Water Loss (TEWL) [48 hours]

   Assessment of water evaporation (TWEL) based upon diffusion principle

3. Transepidermal Water Loss (TEWL) [72 hours]

   Assessment of water evaporation (TWEL) based upon diffusion principle

4. Transepidermal Water Loss (TEWL) [96 hours]

   Assessment of water evaporation (TWEL) based upon diffusion principle

Secondary Outcome Measures

1. Erythema [24 hours]

   Irritancy Grading on a 0-4 scale

2. Erythema [48 hours]

   Irritancy Grading on a 0-4 scale

3. Erythema [72 hours]

   Irritancy Grading on a 0-4 scale

4. Erythema [96 hours]

   Irritancy Grading on a 0-4 scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princeton Research Corporation	Chelmsford	Essex	United Kingdom	CM2 6UA

Sponsors and Collaborators

• Omeza, LLC

Investigators

• Principal Investigator: Barrie Drewitt, PCR Corp
• Study Director: Andrew King, PCR Corp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omeza, LLC
• ClinicalTrials.gov Identifier: NCT04512274
• Other Study ID Numbers: OMZIFL3M
• First Posted: Aug 13, 2020
• Last Update Posted: Aug 13, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Erythema

Study Results

No Results Posted as of Aug 13, 2020