ErythemaNCT04510675

Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

A study testing Test Article in people with Erythema and Sensitisation, run by Omeza, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Erythema, Sensitisation
What is being tested?: Test Article
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2019to 11 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 15Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

PCR Corp
St. Petersburg, Florida, 33702

Other trials in United States

About this study

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

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.

Conditions: Erythema, Sensitisation
Being tested: Test Article, Negative Control
Medical subject headings: Erythema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test ArticleDevice
Omeza Collagen Matrix
Negative ControlOther
Occlusive Patch of 0.9% sodium chloride, NaCl

Study groups in NCT04510675
Study group	Role	What they receive
Test Article (Omeza Collagen Matrix)	Experimental	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. Receives: Device: Test Article
Negative Control (0.9% aqueous sodium chloride)	Experimental	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. Receives: Other: Negative Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24, 48, 72, and 96 Hours

Secondary outcomes (1)

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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 201911 Jan 2020

First posted12 Aug 2020
Study start2 Dec 2019
Primary completion11 Jan 2020
Study completion11 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ErythemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Model description: The study design is based on a Modified Draize Human Repeat Insult Patch Test.
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04510675
Sponsor's protocol ID: OMZRIP1F
Status last verified: Feb 2023
First submitted: 10 Aug 2020
Last updated: 17 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Erythema trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04510675
Acronym / sponsor ID: OMZRIP1F
Conditions: Erythema, Sensitisation
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Omeza, LLCIndustry (pharma, biotech, devices)
Study start: 2 Dec 2019 (actual)
Primary completion: 11 Jan 2020 (actual)
Study completion: 11 Jan 2020 (actual)
First posted: 12 Aug 2020 (actual)
Results: Posted 17 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: The study design is based on a Modified Draize Human Repeat Insult Patch Test.

Arm	Type	Receives
Test Article (Omeza Collagen Matrix)	Experimental	Device: Test ArticleRepetitive 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.
Negative Control (0.9% aqueous sodium chloride)	Experimental	Other: Negative ControlRepetitive 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Test ArticleOmeza Collagen Matrix	Device	Test Article (Omeza Collagen Matrix)
Negative ControlOcclusive Patch of 0.9% sodium chloride, NaCl	Other	Negative Control (0.9% aqueous sodium chloride)

Primary outcome

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.

1 secondary outcome

Adverse Events Deemed Related to the Test Product or the Study
Time frame: 6 weeks

Results and safety

Results posted to the registry on 17 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Article (Omeza Collagen Matrix) and Negative Control (Occlusive Patch of 0.9% NaCl)	58	53

Primary outcome: Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix

Time frame: 24, 48, 72, and 96 Hours. Count of participants. Unit: Participants

Measure	Test Article (Omeza Collagen Matrix) n = 53	Negative Control (0.9% Aqueous Sodium Chloride) n = 53
Frequency of Irritation Score 0 at 24 Hours	53	49
Frequency of Irritation Score + at 24 Hours	0	4
Frequency of Irritation Score 1 at 24 Hours	0	0
Frequency of Irritation Score 2 at 24 Hours	0	0
Frequency of Irritation Score 3 at 24 Hours	0	0
Frequency of Irritation Score 0 at 48 Hours	52	50
Frequency of Irritation Score + at 48 Hours	1	3
Frequency of Irritation Score 1 at 48 Hours	0	0

Population analysed: 58 subjects were enrolled with 53 subjects completing the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored throughout the study with each patient monitored over the 6 weeks of treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Article (Omeza Collagen Matrix) and Negative Control	0 of 58 (0%)	1 of 58 (1.7%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Erythema

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lynne Ellis, MD principal investigator

PCR Corp

Lori DeCaro study director

PCR Corp

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Article in people with Erythema and Sensitisation, run by Omeza, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix (time frame: 24, 48, 72, and 96 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.