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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04510675
Other study ID # OMZRIP1F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2, 2019
Est. completion date January 11, 2020

Study information

Verified date February 2023
Source Omeza, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Test Article
Omeza Collagen Matrix
Other:
Negative Control
Occlusive Patch of 0.9% sodium chloride, NaCl

Locations

Country Name City State
United States PCR Corp Saint Petersburg Florida

Sponsors (1)

Lead Sponsor Collaborator
Omeza, LLC

Country where clinical trial is conducted

United States, 

Outcome

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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