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

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
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

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Number of Participants With Adverse Events [ Time Frame: Week 2, 4, 6, and 12 ] [ Designated as safety issue: Yes ]
Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks [ Time Frame: 12 week posttreatment visit ] [ Designated as safety issue: No ]

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
Aldara: Experimental Aldara (imiquimod) cream 5%	Drug: Imiquimod 5% cream Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks

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

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

Investigators

Study Director:

TC Meng, Dr.

Graceway Pharmaceuticals, LLC

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.

Responsible Party:	Graceway Pharmaceuticals ( Dr. TC Meng, Executive Director Medical Affairs )
Study ID Numbers:	1413-IMIQ
Study First Received:	September 13, 2005
Results First Received:	October 30, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00189306 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

Superficial Basal Cell Carcinoma
Aldara

Study placed in the following topic categories:

Immunologic Factors
Interferons
Adjuvants, Immunologic
Neoplasms, Basal Cell

Imiquimod
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Carcinoma, Basal Cell

Imiquimod
Pharmacologic Actions
Carcinoma
Neoplasms
Therapeutic Uses
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009