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

Graceway Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Superficial Basal Cell Carcinoma

Treatments: Drug: Imiquimod 5% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189306

1413-IMIQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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169 participants in 1 patient group

Aldara

Experimental group

Description:

Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks

Treatment:

Drug: Imiquimod 5% cream