Allergic ReactionNCT04510376
Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
A study testing Test Article in people with Allergic Reaction, run by Omeza, LLC at 1 site in United States.
Trial summary
Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Reaction
- What is being tested?
- Test Article
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 14 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged 18 years of age and older as demonstrated by selfreported medical history, concurrent medication, and a brief dermal skin assessment of the test sites;
- Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information;
- Subject has normal healthy skin on the either volar forearm.
Who cannot join
- Subjects must be excluded if any of the following conditions exist:
- Self-reported pregnant or nursing at the screening visit;
- Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
- History of drug abuse or current drug user;
- Treatment with antihistamine or steroid (any route) administered within the last 7 days;
- History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax);
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- Persistent severe/ unstable asthma;
- Subjects on beta blockers and/or ACE inhibitors;
- Medical condition which in the opinion of the Investigator would compromise the safety of the subject or confound study results (Subjects with the following conditions: chronic renal failure, CVA, cancer, spinal cord injury, diabetic neuropathy, recent anaphylaxis, limbs affected by lymphoedema, paralysis, or neurogenic abnormalities;
- Diabetic (type 1 or 2);
- Subjects taking the following: Antidepressants such as doxepin, other tricyclics, Phenothiazines, and tetracyclics within the last two weeks;
- Subjects taking OTC cold and flu remedies, "sinus" analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen);
- Prolonged use of topical corticosteroids;
- Use of topical moisturizers on the volar forearms;
- Dermographism "writing on the skin" - common localized hive reaction, characterized by the abrupt onset of welts and hives where the skin is exposed to pressure, scratching, itching, or stroking;
- Investigator deems the subject an unsuitable candidate for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects
- Conditions
- Allergic Reaction
- Being tested
- Test Article, Positive Control, Negative Control
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ArticleDevice
Omeza Collagen Matrix
Positive ControlOther
1.0 mg/mL Histamine Base
Negative ControlOther
Aqueous Negative Control
| Study group | Role | What they receive |
|---|---|---|
| Test article | Experimental | Not described Receives: Device: Test Article |
| Histamine Positive Skin Test Control | Active comparator | Not described Receives: Other: Positive Control |
| Aqueous Negative Control | Placebo comparator | Not described Receives: Other: Negative Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic Reaction
Response of at least 3-mm diameter (with equivalent erythema) more than negative control is required as proof of presence of cutaneous allergen specific IgE
Measured: 20 minutes
Secondary outcomes (1)
Allergic Reaction
Latent reaction to skin prick (safety assessment)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start14 Nov 2019
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ReactionStudies 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
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynne Ellis, M.D., Principal investigator, PCR CorpLori Decaro, Study director, PCR Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510376
- Sponsor's protocol ID
- OMZPRI1F
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study to Assess the Allergy Potential of Omeza Collagen Matrix in Human Subjects Using the Skin Prick Method
- ClinicalTrials.gov ID
- NCT04510376
- Acronym / sponsor ID
- OMZPRI1F
- Conditions
- Allergic Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of Omeza Collagen Matrix in Human Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test article | Experimental | Device: Test Article |
| Histamine Positive Skin Test Control | Active comparator | Other: Positive Control |
| Aqueous Negative Control | Placebo comparator | Other: Negative Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers aged 18 years of age and older as demonstrated by selfreported medical history, concurrent medication, and a brief dermal skin assessment of the test sites;
- Fully informed of the risks of entering the study and willing to provide written informed consent and HIPAA authorization to disclose protected health information;
- Subject has normal healthy skin on the either volar forearm.
Key exclusion criteria (16 listed)
- Self-reported pregnant or nursing at the screening visit;
- Clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
- History of drug abuse or current drug user;
- Treatment with antihistamine or steroid (any route) administered within the last 7 days;
- History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax);
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 |
| Positive Control1.0 mg/mL Histamine Base | Other | Histamine Positive Skin Test Control |
| Negative ControlAqueous Negative Control | Other | Aqueous Negative Control |
Primary outcome
Allergic Reaction
Time frame: 20 minutes
Response of at least 3-mm diameter (with equivalent erythema) more than negative control is required as proof of presence of cutaneous allergen specific IgE
1 secondary outcome
Allergic Reaction
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Allergy Diagnostic Testing: An Updated Practice ParameterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, M.D. 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 Allergic Reaction, 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 3 inclusion and 16 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 12 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Allergic Reaction (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2020.