Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Erythema, Sensitisation

Intervention / Treatment
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* Device: Test Article
* Other: Negative Control


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The study design is based on a Modified Draize Human Repeat Insult Patch Test.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Article (Omeza Collagen Matrix)<br>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<br>* Omeza Collagen Matrix<br>|
| Experimental: Negative Control (0.9% aqueous sodium chloride)<br>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<br>* Occlusive Patch of 0.9% sodium chloride, NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |