Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

Erythema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510675
• Other study ID #: OMZRIP1F
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: January 11, 2020

Study information

• Verified date: February 2023
• Source: Omeza, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 11, 2020
• Est. primary completion date: January 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Erythema
• Sensitisation

Intervention

Device:
• Test Article
Omeza Collagen Matrix

Other:
• Negative Control
Occlusive Patch of 0.9% sodium chloride, NaCl

Locations

Country	Name	City	State
United States	PCR Corp	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Omeza, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 weeks