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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189267

Enrollment

Registered

2005-09-19

Start date

2002-11-30

Completion date

2005-09-30

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Aldara, Actinic Keratosis, Graft Recipients

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.

Interventions

DRUGImiquimod 5 % Cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026