NCT00492895

Brief Summary

Photosensitivity of the skin to UVA and UVB will be determined

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

3.5 years

First QC Date

June 19, 2007

Last Update Submit

January 28, 2013

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (1)

  • Photosensitivity of the skin to UVA and UVB

    2 years

Study Arms (1)

A

OTHER

one arm only. Crossover study

Drug: Discontinuation of Azathioprin

Interventions

Discontinuation of AzathioprinDRUG

Discontinuation of Azathioprin

A

Eligibility Criteria

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

You may qualify if:

  • Renal transplant recipients under azathioprin

You may not qualify if:

  • Treatment with Prograf (Tacrolimus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Dermatology, University Hospital of Zurich

Zurich, Switzerland

Location

Related Publications (1)

  • Hofbauer GF, Attard NR, Harwood CA, McGregor JM, Dziunycz P, Iotzova-Weiss G, Straub G, Meyer R, Kamenisch Y, Berneburg M, French LE, Wuthrich RP, Karran P, Serra AL. Reversal of UVA skin photosensitivity and DNA damage in kidney transplant recipients by replacing azathioprine. Am J Transplant. 2012 Jan;12(1):218-25. doi: 10.1111/j.1600-6143.2011.03751.x. Epub 2011 Sep 22.

    PMID: 21943390RESULT

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Günther Hofbauer, M.D

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 27, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

CH(1)