Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

Not Applicable

Completed

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.

Recruitment & 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).

Primary Outcome Measures

Name	Time	Method
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix	24, 48, 72, and 96 Hours	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events Deemed Related to the Test Product or the Study	6 weeks	The secondary outcome measure is the number of adverse events deemed related to the test article or the study.