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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Imiquimod 5 % Cream

Drug

Primary outcomes

Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.

Secondary outcomes

Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study title

Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream Applied Once Daily 3 Days Per Week for the Treatment of Actinic Keratoses in Immunosuppressed Organ Transplant Recipients.

Important dates

Study start: 2002
Study completion: 2005
First posted: Sep 19, 2005
Registry last updated: Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed