NCT00488384

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

7.5 years

First QC Date

June 19, 2007

Last Update Submit

July 17, 2018

Conditions

Carcinoma, Squamous Cell

Keywords

Squamous cell carcinoma of the skin under hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Plasma levels acitretin

    2009

Study Arms (1)

a

OTHER

single arm only. Only open label treatment anticipated

Drug: Chemopreventive application (Acitretin)

Interventions

Chemopreventive application (Acitretin)DRUG

Chemopreventive application (Acitretin)

a

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hepatopathy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Dermatology University Hospital of Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Acitretin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological Factors

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior staff physician

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2014

Study Completion

June 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

CH(1)