Status:
COMPLETED
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
Lead Sponsor:
Omeza, LLC
Conditions:
Erythema
Sensitisation
Eligibility:
All Genders
18-65 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04510675
Start Date
December 2 2019
End Date
January 11 2020
Last Update
May 17 2023
Active Locations (1)
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1
PCR Corp
St. Petersburg, Florida, United States, 33702