Transepidermal Water LossNCT04512274
Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
A study testing Test Article in people with Transepidermal Water Loss and Erythema, run by Omeza, LLC at 1 site in United Kingdom.
Trial summary
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transepidermal Water Loss, Erythema
- 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
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 5 Jun 2020
- 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
- Subject is a healthy male or female, aged 18 years or older.
- Subject has signed a written Informed Consent.
Who cannot join
- Pregnancy or lactation.
- Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
- A current skin disease of any type at the test site (e.g. eczema, psoriasis)
- Heavy alcohol consumption in the opinion of the investigator.
- A fever in the last 12 hours, prior to the initial patch application.
- Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
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- History of malignant disease.
- Insulin dependent or non-insulin dependent diabetes.
- Concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids).
- Known sensitivity to the treatment solutions or their constituents including patch materials.
- Sensitisation or questionable sensitisation in a Repeat Insult Patch Test.
- Use of self-tanning lotion on the test area, one week previous to the start of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Princeton Research Corporation
Chelmsford, Essex, CM2 6UA
About this study
Official title: A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
Read the detailed description
This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.
For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.
An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.
- Conditions
- Transepidermal Water Loss, Erythema
- Being tested
- Test Article
- 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
| Study group | Role | What they receive |
|---|---|---|
| Test Article | Experimental | The test article was applied to an open application site and to a second site of induced inflammation Receives: Device: Test Article |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury
Measured: 24 hours
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Measured: 48 hours
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Measured: 72 hours
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Measured: 96 hours
Secondary outcomes (4)
Erythema
Irritancy Grading on a 0-4 scale
Measured: 24 hours
Erythema
Irritancy Grading on a 0-4 scale
Measured: 48 hours
Erythema
Irritancy Grading on a 0-4 scale
Measured: 72 hours
Erythema
Irritancy Grading on a 0-4 scale
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Jun 2020
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transepidermal Water LossStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeza, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barrie Drewitt, Principal investigator, PCR CorpAndrew King, Study director, PCR Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512274
- Sponsor's protocol ID
- OMZIFL3M
- Status last verified
- Sep 2022
- First submitted
- 11 Aug 2020
- Last updated
- 30 Sep 2022
- 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin
- ClinicalTrials.gov ID
- NCT04512274
- Acronym / sponsor ID
- OMZIFL3M
- Conditions
- Transepidermal Water Loss, Erythema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Omeza, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 13 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-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
Detailed description
This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.
For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.
An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Article | Experimental | Device: Test ArticleThe test article was applied to an open application site and to a second site of induced inflammation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is a healthy male or female, aged 18 years or older.
- Subject has signed a written Informed Consent.
Key exclusion criteria (12 listed)
- Pregnancy or lactation.
- Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
- A current skin disease of any type at the test site (e.g. eczema, psoriasis)
- Heavy alcohol consumption in the opinion of the investigator.
- A fever in the last 12 hours, prior to the initial patch application.
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 |
Primary outcome
Transepidermal Water Loss (TEWL)
Time frame: 24 hours
Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury
Transepidermal Water Loss (TEWL)
Time frame: 48 hours
Assessment of water evaporation (TWEL) based upon diffusion principle
Transepidermal Water Loss (TEWL)
Time frame: 72 hours
Assessment of water evaporation (TWEL) based upon diffusion principle
Transepidermal Water Loss (TEWL)
Time frame: 96 hours
Assessment of water evaporation (TWEL) based upon diffusion principle
4 secondary outcomes
Erythema
Time frame: 24 hours
Erythema
Time frame: 48 hours
Erythema
Time frame: 72 hours
Erythema
Time frame: 96 hours
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 30 Sep 2022.
- 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.
Barrie Drewitt principal investigator
PCR Corp
Andrew King 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 Transepidermal Water Loss and Erythema, run by Omeza, LLC at 1 site in United Kingdom.
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 2 inclusion and 12 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 30 Sep 2022. 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 Kingdom. 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?
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?
Transepidermal Water Loss (TEWL) (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 30 Sep 2022.