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Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

Primary Purpose

Erythema, Sensitisation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Article
Negative Control
Sponsored by
Omeza, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erythema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Good general health, as assessed by medical history and brief dermal skin examination of the application site (back);
  • Was fully informed of the risks of entering the study and was willing to provide written consent to enter the study;
  • Was willing to follow study rules, which included: no sun exposure (for example; no swimming, sunbathing, or tanning beds), avoided activities that would cause excessive sweating, abstained from use of lotions, creams, or oils on the back area;
  • Was willing to not change current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study;
  • Was willing and able to practice an acceptable measure of contraception (i.e. birth control medication for at least 3 months prior, condom with spermicide or birth control injections,) during the study, if female of childbearing potential. To be considered female of non-childbearing potential, subject must have had a hysterectomy, tubal ligation, or had been post-menopausal for at least 1 year.

Exclusion Criteria:

  • Clinically significant skin disease which contraindicated participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
  • Asthma that required medication;
  • Insulin-dependent diabetes;
  • Known immunological disorders such as HIV positive, AIDS and systemic lupus
  • erythematosus;
  • Treatment for any type of cancer within the last six months;
  • Routine use (as defined by using more than 3 days in a week) of any anti-inflammatory drug (e.g., aspirin, ibuprofen, corticosteroids; 81 mg aspirin is acceptable), immunosuppressive drugs, antihistamine medication (steroid nose drops and/or eye drops are acceptable) or over-the-counter pain medication that was ingested in quantities exceeding label instructions;
  • Use of topical drugs at patch site;
  • Pregnancy, lactation, or planning a pregnancy (confirmed by a urine pregnancy test administered to females of childbearing potential);
  • Medical condition which, in the Investigator's judgement, made the subject
  • ineligible or placed the subject at undue risk;
  • Participation in any patch test for irritation or sensitization within the last four weeks;
  • Dermatological aberrations in or around test sites which included sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or any other disfiguration of the test site;
  • Confirmed allergy to adhesives, bandages, or ingredients in OmezaTM Collagen Matrix;
  • History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax).

Sites / Locations

  • PCR Corp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Test Article (Omeza Collagen Matrix)

Negative Control (0.9% aqueous sodium chloride)

Arm Description

Repetitive and continuous patch applications of the test article to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.

Repetitive and continuous patch applications of the negative control to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.

Outcomes

Primary Outcome Measures

Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.

Secondary Outcome Measures

Adverse Events Deemed Related to the Test Product or the Study
The secondary outcome measure is the number of adverse events deemed related to the test article or the study.

Full Information

First Posted
August 10, 2020
Last Updated
April 26, 2023
Sponsor
Omeza, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04510675
Brief Title
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
Official Title
A 6-Week, Randomized, Evaluator-Blinded, In Vivo Within Subject Repeat Test to Evaluate the Irritation and Sensitization Potential of Omeza Collagen Matrix in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
January 11, 2020 (Actual)
Study Completion Date
January 11, 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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Sensitisation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study design is based on a Modified Draize Human Repeat Insult Patch Test.
Masking
None (Open Label)
Masking Description
The trained skin evaluator and Investigator was blinded to the identity of the test materials. Test/control sites were randomized within participants.
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Article (Omeza Collagen Matrix)
Arm Type
Experimental
Arm Description
Repetitive and continuous patch applications of the test article to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.
Arm Title
Negative Control (0.9% aqueous sodium chloride)
Arm Type
Experimental
Arm Description
Repetitive and continuous patch applications of the negative control to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.
Intervention Type
Device
Intervention Name(s)
Test Article
Intervention Description
Omeza Collagen Matrix
Intervention Type
Other
Intervention Name(s)
Negative Control
Intervention Description
Occlusive Patch of 0.9% sodium chloride, NaCl
Primary Outcome Measure Information:
Title
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Description
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.
Time Frame
24, 48, 72, and 96 Hours
Secondary Outcome Measure Information:
Title
Adverse Events Deemed Related to the Test Product or the Study
Description
The secondary outcome measure is the number of adverse events deemed related to the test article or the study.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Good general health, as assessed by medical history and brief dermal skin examination of the application site (back); Was fully informed of the risks of entering the study and was willing to provide written consent to enter the study; Was willing to follow study rules, which included: no sun exposure (for example; no swimming, sunbathing, or tanning beds), avoided activities that would cause excessive sweating, abstained from use of lotions, creams, or oils on the back area; Was willing to not change current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study; Was willing and able to practice an acceptable measure of contraception (i.e. birth control medication for at least 3 months prior, condom with spermicide or birth control injections,) during the study, if female of childbearing potential. To be considered female of non-childbearing potential, subject must have had a hysterectomy, tubal ligation, or had been post-menopausal for at least 1 year. Exclusion Criteria: Clinically significant skin disease which contraindicated participation, including psoriasis, eczema, atopic dermatitis, and active cancer; Asthma that required medication; Insulin-dependent diabetes; Known immunological disorders such as HIV positive, AIDS and systemic lupus erythematosus; Treatment for any type of cancer within the last six months; Routine use (as defined by using more than 3 days in a week) of any anti-inflammatory drug (e.g., aspirin, ibuprofen, corticosteroids; 81 mg aspirin is acceptable), immunosuppressive drugs, antihistamine medication (steroid nose drops and/or eye drops are acceptable) or over-the-counter pain medication that was ingested in quantities exceeding label instructions; Use of topical drugs at patch site; Pregnancy, lactation, or planning a pregnancy (confirmed by a urine pregnancy test administered to females of childbearing potential); Medical condition which, in the Investigator's judgement, made the subject ineligible or placed the subject at undue risk; Participation in any patch test for irritation or sensitization within the last four weeks; Dermatological aberrations in or around test sites which included sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or any other disfiguration of the test site; Confirmed allergy to adhesives, bandages, or ingredients in OmezaTM Collagen Matrix; History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Ellis, MD
Organizational Affiliation
PCR Corp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lori DeCaro
Organizational Affiliation
PCR Corp
Official's Role
Study Director
Facility Information:
Facility Name
PCR Corp
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

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