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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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Imiquimod 5 % Cream

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Aldara, Actinic Keratosis, Graft Recipients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00189267

First Posted

September 12, 2005

Last Updated

February 4, 2022

Sponsor

MEDA Pharma GmbH & Co. KG

1. Study Identification

Unique Protocol Identification Number

NCT00189267

Brief Title

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

Official 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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

MEDA Pharma GmbH & Co. KG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

Aldara, Actinic Keratosis, Graft Recipients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Imiquimod 5 % Cream

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Coordinator

Organizational Affiliation

Universitaetsklinikum Charite

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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