Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

NCT ID: NCT04510675

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2020-01-11

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Test Article (Omeza Collagen Matrix)

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.

Group Type: EXPERIMENTAL

Test Article

Intervention Type: DEVICE

Omeza Collagen Matrix

Negative Control (0.9% aqueous sodium chloride)

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.

Group Type: EXPERIMENTAL

Negative Control

Intervention Type: OTHER

Occlusive Patch of 0.9% sodium chloride, NaCl

Interventions

Test Article

Omeza Collagen Matrix

Intervention Type: DEVICE

Negative Control

Occlusive Patch of 0.9% sodium chloride, NaCl

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Omeza, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

PCR Corp

Lori DeCaro

Role: STUDY_DIRECTOR

PCR Corp

Locations

PCR Corp

St. Petersburg, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OMZRIP1F

Identifier Type: -

Identifier Source: org_study_id