Carcinoma, Squamous CellPhase 4NCT00488384
Acitretin Plasma Levels Under Hemodialysis
A Phase 4 study testing Chemopreventive application (Acitretin) in people with Carcinoma, Squamous Cell, run by Günther Hofbauer at 1 site in Switzerland.
Trial summary
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Chemopreventive application (Acitretin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2007to Jun 2018
- Phase
- Phase 4
- 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
- Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin
Who cannot join
- Hepatopathy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Dermatology University Hospital of Zurich
Zurich
About this study
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.
Read the detailed description
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined.
- Trial with medicinal product
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Chemopreventive application (Acitretin)
- Keywords
- Squamous cell carcinoma of the skin under hemodialysis
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemopreventive application (Acitretin)Drug
Chemopreventive application (Acitretin)
| Study group | Role | What they receive |
|---|---|---|
| a | Other | single arm only. Only open label treatment anticipated Receives: Drug: Chemopreventive application (Acitretin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels acitretin
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2014
- Study completionJun 2018
Why it stopped: lack of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Günther Hofbauer
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Günther Hofbauer, University of Zurich
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488384
- Sponsor's protocol ID
- 2007DR2065 EK674
- Status last verified
- Jul 2018
- First submitted
- 19 Jun 2007
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acitretin Plasma Levels Under Hemodialysis
- ClinicalTrials.gov ID
- NCT00488384
- Acronym / sponsor ID
- 2007DR2065 EK674
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Squamous cell carcinoma of the skin under hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Günther HofbauerUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jun 2007 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 20 Jun 2007 (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.
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.
Detailed description
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined.
- Trial with medicinal product
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a | Other | Drug: Chemopreventive application (Acitretin)single arm only. Only open label treatment anticipated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin
Key exclusion criteria (2 listed)
- Hepatopathy
- Pregnancy
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 |
|---|---|---|
| Chemopreventive application (Acitretin)Chemopreventive application (Acitretin) | Drug | a |
Primary outcome
Plasma levels acitretin
Time frame: 2009
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chemopreventive application (Acitretin) in people with Carcinoma, Squamous Cell, run by Günther Hofbauer at 1 site in Switzerland.
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 2 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: withdrawn, as of the sponsor's last update on 19 Jul 2018. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Plasma levels acitretin (time frame: 2009). 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 19 Jul 2018; AzTrials last refreshed its copy on 1 Nov 2026.