Clinical trial NCT04510675: Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Sensitisation
Lead sponsor: Omeza, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study design is based on a Modified Draize Human Repeat Insult Patch Test.
Primary purpose: BASIC_SCIENCE

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 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 outcomes:
measure: Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
timeFrame: 24, 48, 72, and 96 Hours
Secondary outcomes:
measure: Adverse Events Deemed Related to the Test Product or the Study
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: PCR Corp
state: Florida
Study officials:
affiliation: PCR Corp
name: Lynne Ellis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PCR Corp
name: Lori DeCaro
role: STUDY_DIRECTOR
References: