- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510675
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Saint Petersburg, Florida, United States, 33702
- PCR Corp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Article (Omeza Collagen Matrix)
Repetitive and continuous patch applications of the test article to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time. |
Omeza Collagen Matrix
|
Experimental: Negative Control (0.9% aqueous sodium chloride)
Repetitive and continuous patch applications of the negative control to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time. |
Occlusive Patch of 0.9% sodium chloride, NaCl
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Time Frame: 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.
|
24, 48, 72, and 96 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events Deemed Related to the Test Product or the Study
Time Frame: 6 weeks
|
The secondary outcome measure is the number of adverse events deemed related to the test article or the study.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lynne Ellis, MD, PCR Corp
- Study Director: Lori DeCaro, PCR Corp
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMZRIP1F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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