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

Sponsor:	Medicis Global Service Corporation
Information provided by:	Medicis Global Service Corporation
ClinicalTrials.gov Identifier:	NCT00189306

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 III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

Drug Information available for: S 26308

U.S. FDA Resources

Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:

Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Dermatology Practice
Christchurch, New Zealand
Colombo Mansions
Christchurch, New Zealand
Skin Institute Limited
Takapuna, New Zealand

Sponsors and Collaborators

Medicis Global Service Corporation

Investigators

Study Director:

Jim Lee, Dr.

Medicis Global Service Corporation

More Information

Publications:

Quirk C, Gebauer K, Owens M, Stampone P. Two-year interim results from a 5-year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks. Australas J Dermatol. 2006 Nov;47(4):258-65.

Quirk C, Gebauer K, De'Ambrosis B, Slade HB, Meng TC. Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis. 2010 Jun;85(6):318-24.

Responsible Party:	Medical Director, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00189306 History of Changes
Other Study ID Numbers:	1413-IMIQ
Study First Received:	September 13, 2005
Results First Received:	October 30, 2008
Last Updated:	August 5, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medicis Global Service Corporation:

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on February 09, 2012