HealthyNCT00644436
Study to Determine if Tetrix Cream is Removed From the Hands by Gentle Washing With Soap and Water
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 remains on the hands after gentle washing with soap and water Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal subjects
- Male and Female
Who cannot join
- Under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, South Carolina, 27262
About this study
Official title: A Study of the Substantivity of Tetrix Cream
To determine if Tetrix Cream remains on the hands after gentle washing with soap and water
- Conditions
- Healthy
- Being tested
- Tetrix
- Keywords
- tetrix cream, substantivity, resistance to a gentle wash, Tetrix Cream remaining on hands after gentle washing with soap and water.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrixDevice
single topical application
TetrixDevice
Single topical application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single topical application Receives: Device: Tetrix |
| 2 | Active comparator | Single topical application Receives: Device: Tetrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of Tetrix remaining on the skin compared to control, after gentle washing with soap
Measured: 30 minutes
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 startNov 2007
- Primary completionNov 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coria Laboratories, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zoe Draelos, MD, Principal investigator, Dermatology Consulting Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644436
- Sponsor's protocol ID
- 806 805 09 001
- Status last verified
- Mar 2008
- First submitted
- 20 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Substantivity of Tetrix Cream
- ClinicalTrials.gov ID
- NCT00644436
- Acronym / sponsor ID
- 806 805 09 001
- Conditions
- Healthy
- Keywords
- tetrix cream, substantivity, resistance to a gentle wash, Tetrix Cream remaining on hands after gentle washing with soap and water.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Coria Laboratories, Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 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 remains on the hands after gentle washing with soap and water
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: TetrixSingle topical application |
| 2 | Active comparator | Device: TetrixSingle topical application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal subjects
- Male and Female
Key exclusion criteria (1 listed)
- Under the age of 18 years
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 |
|---|---|---|
| Tetrixsingle topical application | Device | 1 |
| TetrixSingle topical application | Device | 2 |
Primary outcome
amount of Tetrix remaining on the skin compared to control, after gentle washing with soap
Time frame: 30 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 28 Mar 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.
Zoe Draelos, MD principal investigator
Dermatology Consulting Service
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 2 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 28 Mar 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. 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?
amount of Tetrix remaining on the skin compared to control, after gentle washing with soap (time frame: 30 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 28 Mar 2008.