An interventional study of Test Article in Transepidermal Water Loss and Erythema, sponsored by Omeza, LLC. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Omeza, LLC · Not applicable, Interventional, and Basic science
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →Omeza, LLC is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The test article was applied to an open application site and to a second site of induced inflammation
Device: Test Article
Omeza Collagen Matrix
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury
Time frame: 24 hours
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Time frame: 48 hours
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Time frame: 72 hours
Transepidermal Water Loss (TEWL)
Assessment of water evaporation (TWEL) based upon diffusion principle
Time frame: 96 hours
Erythema
Irritancy Grading on a 0-4 scale
Time frame: 24 hours
Erythema
Irritancy Grading on a 0-4 scale
Time frame: 48 hours
Erythema
Irritancy Grading on a 0-4 scale
Time frame: 72 hours
Erythema
Irritancy Grading on a 0-4 scale
Time frame: 96 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Jun 2020, 0 months.
Of 43 interventional studies with no phase under Erythema, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 11. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Omeza, LLC