HealthyNCT00643630
Evaluation of Tetrix Cream as a Protective Barrier Against Injurious Materials
A study testing Tetrix in people with Healthy, run by Coria Laboratories, Ltd. at 1 site in United States.
Trial summary
To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tetrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2007
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal subjects who are sensitized to nickel, neomycin, or fragrance mix.
Who cannot join
- Under 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatolgoy Specialists, LLC
Louisville, Kentucky, 40202
About this study
Official title: A Study to Determine the Skin Barrier Effect of Tetrix Cream
To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin
- Conditions
- Healthy
- Being tested
- Tetrix
- Keywords
- Tetrix crea, skin barrier, antigen reaction, prevention, The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrixDevice
Twice daily topical application
TetrixDevice
Twice daily topical application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Twice daily topical application Receives: Device: Tetrix |
| 2 | Placebo comparator | Twice daily topical application Receives: Device: Tetrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of delayed bype hypersensitivity reaction following application of antigen
Measured: up to 96 hours after antigen application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coria Laboratories, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph Fowler, MD, Principal investigator, Dermatology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643630
- Sponsor's protocol ID
- 806 805 09 002
- Status last verified
- May 2008
- First submitted
- 20 Mar 2008
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Skin Barrier Effect of Tetrix Cream
- ClinicalTrials.gov ID
- NCT00643630
- Acronym / sponsor ID
- 806 805 09 002
- Conditions
- Healthy
- Keywords
- Tetrix crea, skin barrier, antigen reaction, prevention, The efficacy of Tetrix Cream to prevent an antigen reaction on the skin.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Coria Laboratories, Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Mar 2008 (estimated)
- 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.
To determine if Tetrix Cream,, when applied to the skin, acts as a barrier to prevent injury to the skin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: TetrixTwice daily topical application |
| 2 | Placebo comparator | Device: TetrixTwice daily topical application |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal subjects who are sensitized to nickel, neomycin, or fragrance mix.
Key exclusion criteria (1 listed)
- Under 18 years of age.
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 |
|---|---|---|
| TetrixTwice daily topical application | Device | 1 |
| TetrixTwice daily topical application | Device | 2 |
Primary outcome
Prevention of delayed bype hypersensitivity reaction following application of antigen
Time frame: up to 96 hours after antigen application
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 22 May 2008.
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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.
Joseph Fowler, MD principal investigator
Dermatology Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetrix in people with Healthy, run by Coria Laboratories, Ltd. 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 1 inclusion and 1 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 22 May 2008. 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?
Prevention of delayed bype hypersensitivity reaction following application of antigen (time frame: up to 96 hours after antigen application). 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 22 May 2008.