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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189306
First Posted: September 19, 2005
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Graceway Pharmaceuticals, LLC
  Purpose
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.

Condition Intervention Phase
Superficial Basal Cell Carcinoma Drug: Imiquimod 5% cream Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 169
Study Start Date: March 2001
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aldara (imiquimod) 5% cream - 250 mg / packet

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189306


Locations
Australia, New South Wales
Medical Centre, Concord Hospital
Concord, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Australia, Queensland
Skin Centre
Benowa, Queensland, Australia
South East Dermatology Centre
Carina Heights, Queensland, Australia
105 Fulham Road
Gulliver, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, South Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Australia, Victoria
Western Hospital
Footscray, Victoria, Australia
Austin & Repartriation Hospital
Heidelburg, Victoria, Australia
Australia, Western Australia
Freemantle Dermatology
Fremantle, Western Australia, Australia
158 South Terrace
Perth, Western Australia, Australia
Subiaco Clinic
Subiaco, Western Australia, Australia
New Zealand
103A Mountain Road
Epsom, Auckland, New Zealand
Birthcare Building
Parnell, Auckland, New Zealand
Colombo Mansions
Christchurch, New Zealand
Dermatology Practice
Christchurch, New Zealand
Skin Institute Limited
Takapuna, New Zealand
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
Investigators
Study Director: Jim Lee, Dr. Graceway Pharmaceuticals
  More Information

Publications:
Responsible Party: Medical Director, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00189306     History of Changes
Other Study ID Numbers: 1413-IMIQ
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: October 30, 2008
Results First Posted: November 26, 2008
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by Graceway Pharmaceuticals, LLC:
Superficial Basal Cell Carcinoma
Aldara

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers