Acitretin Plasma Levels Under Hemodialysis - Full Text View

Sponsor:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00488384

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Squamous Cell	Drug: Chemopreventive application (Acitretin)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Acitretin Plasma Levels Under Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: Acitretin

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Plasma levels acitretin [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2009
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
a single arm only. Only open label treatment anticipated	Drug: Chemopreventive application (Acitretin) Chemopreventive application (Acitretin) Other Name: Chemopreventive application (Acitretin)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin

Exclusion criteria:

Hepatopathy
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488384

Locations

Switzerland
Clinic for Dermatology University Hospital of Zurich
Zurich, Switzerland

Sponsors and Collaborators

University of Zurich

Investigators

Study Director:

01 Studienregister MasterAdmins

UniversitaetsSpital Zuerich

More Information

No publications provided

Responsible Party:	hofbauer, university hospital zurich
ClinicalTrials.gov Identifier:	NCT00488384 History of Changes
Other Study ID Numbers:	2007DR2065 EK674
Study First Received:	June 19, 2007
Last Updated:	August 18, 2011
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

Squamous cell carcinoma of the skin under hemodialysis

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

Acitretin
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012