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
Verified date | February 2023 |
Source | Omeza, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United States | PCR Corp | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
Omeza, LLC |
United States,
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 |
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