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

Superficial Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189306
• Other study ID #: 1413-IMIQ
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: August 5, 2010
• Start date: March 2001
• Est. completion date: April 2007

Study information

• Verified date: August 2010
• Source: Graceway Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Superficial Basal Cell Carcinoma

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Graceway Pharmaceuticals, LLC

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)	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	No
Secondary	Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks	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	No