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.

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).

Adverse events were monitored throughout the study with each patient monitored over the 6 weeks of treatment.

Since both the test article and negative control were administered at the same time, it would not be possible to determine if any systemic adverse events were related to the test article or the negative control. As such, the arms are combined for the adverse event record.

The trained skin evaluator and Investigator was blinded to the identity of the test materials. Test/control sites were randomized within participants.