Clinical trial NCT00189306: Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Superficial Basal Cell Carcinoma
Keywords: Superficial Basal Cell Carcinoma
Aldara
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
timeFrame: 5 years
Secondary outcomes:
measure: Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
timeFrame: 12 week posttreatment visit
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Medical Centre, Concord Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Skin Centre
state: Queensland
city: Carina Heights
country: Australia
facility: South East Dermatology Centre
state: Queensland
city: Gulliver
country: Australia
facility: 105 Fulham Road
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Heidelburg
country: Australia
facility: Austin & Repartriation Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Freemantle Dermatology
state: Western Australia
city: Perth
country: Australia
facility: 158 South Terrace
state: Western Australia
city: Subiaco
country: Australia
facility: Subiaco Clinic
state: Western Australia
city: Epsom
country: New Zealand
facility: 103A Mountain Road
state: Auckland
city: Parnell
country: New Zealand
facility: Birthcare Building
state: Auckland
city: Christchurch
country: New Zealand
facility: Colombo Mansions
city: Christchurch
country: New Zealand
facility: Dermatology Practice
city: Takapuna
country: New Zealand
facility: Skin Institute Limited
Study officials:
affiliation: Graceway Pharmaceuticals
name: Jim Lee, Dr.
role: STUDY_DIRECTOR
References:
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. doi: 10.1111/j.1440-0960.2006.00313.x.
citation: 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.