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

Graceway Pharmaceuticals, LLC169 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

169

Conditions

Superficial Basal Cell Carcinoma

Interventions

Imiquimod 5% creamDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Medical Centre, Concord Hospital

Concord, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

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)

Time frame: 12 week posttreatment visit

Data from ClinicalTrials.gov

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