Status:

COMPLETED

A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients

Lead Sponsor:

MEDA Pharma GmbH & Co. KG

Conditions:

Actinic Keratosis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.

Eligibility Criteria

Inclusion

  • Have a total of 4-10 actinic keratosis (AK) lesions located on either face or scalp
  • If female and of childbearing potential, have a negative urine pregnancy test at treatment initiation, and willing to use a medically acceptable method of contraception during the treatment period
  • Renal, liver or heart transplant recipients

Exclusion

  • Graft rejection with loss of the graft in the medical history
  • Unstable status of organ transplant disease during the last 12 months
  • Known to be pregnant or lactating

Key Trial Info

Start Date :

November 1 2002

Trial Type :

INTERVENTIONAL

End Date :

September 1 2005

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00189267

Start Date

November 1 2002

End Date

September 1 2005

Last Update

February 7 2022

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