Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

August 5, 2010 updated by: Graceway Pharmaceuticals, LLC

An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia
        • Medical Centre, Concord Hospital
      • Randwick, New South Wales, Australia
        • Prince of Wales Hospital
    • Queensland
      • Benowa, Queensland, Australia
        • Skin Centre
      • Carina Heights, Queensland, Australia
        • South East Dermatology Centre
      • Gulliver, Queensland, Australia
        • 105 Fulham Road
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia
        • Flinders Medical Center
      • Woodville, South Australia, Australia
        • Queen Elizabeth Hospital
    • Victoria
      • Footscray, Victoria, Australia
        • Western Hospital
      • Heidelburg, Victoria, Australia
        • Austin & Repartriation Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Freemantle Dermatology
      • Perth, Western Australia, Australia
        • 158 South Terrace
      • Subiaco, Western Australia, Australia
        • Subiaco Clinic
  • New Zealand
      • Christchurch, New Zealand
        • Colombo Mansions
      • Christchurch, New Zealand
        • Dermatology Practice
      • Takapuna, New Zealand
        • Skin Institute Limited
    • Auckland
      • Epsom, Auckland, New Zealand
        • 103A Mountain Road
      • Parnell, Auckland, New Zealand
        • Birthcare Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have at least 1 previously untreated superficial basal cell carcinoma tumor
  • Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

Exclusion Criteria:

  • Evidence of clinically significant, unstable medical conditions
  • Cannot have recent use of topical steroids or retinoids in the treatment area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aldara
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Drug: Imiquimod 5% cream
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Other Names:
  • Aldara (imiquimod) 5% cream - 250 mg / packet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
Time Frame: 5 years
Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
Time Frame: 12 week posttreatment visit
Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)
12 week posttreatment visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Graceway Pharmaceuticals, LLC

Investigators

  • Study Director: Jim Lee, Dr., Graceway Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 5, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1413-IMIQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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