Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

NCT04510675 | Completed Results FDA Device

• 1 other identifier: OMZRIP1F
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythema; Sensitisation

Outcome Measures

Primary Outcomes (1)

• 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.

  24, 48, 72, and 96 Hours

Secondary Outcomes (1)

• Adverse Events Deemed Related to the Test Product or the Study

  6 weeks

Study Arms (2)

Test Article (Omeza Collagen Matrix)

EXPERIMENTAL

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.

Device: Test Article

Negative Control (0.9% aqueous sodium chloride)

EXPERIMENTAL

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.

Other: Negative Control

Interventions

Test Article DEVICE

Omeza Collagen Matrix

Test Article (Omeza Collagen Matrix)

Negative Control OTHER

Occlusive Patch of 0.9% sodium chloride, NaCl

Negative Control (0.9% aqueous sodium chloride)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Omeza, LLC: lead

Study Sites (1)

PCR Corp

St. Petersburg, Florida, 33702, United States

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

Results Point of Contact

• Title: Principal Investigator
• Organization: Princeton Consumer Research Corp.

bd@princetonconsumer.com

727-576-7300

Study Officials

• Lynne Ellis, MD

  PCR Corp

  PRINCIPAL INVESTIGATOR

• Lori DeCaro

  PCR Corp

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The trained skin evaluator and Investigator was blinded to the identity of the test materials. Test/control sites were randomized within participants.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study design is based on a Modified Draize Human Repeat Insult Patch Test.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: December 2, 2019
• Primary Completion: January 11, 2020
• Study Completion: January 11, 2020
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)