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

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2007

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
    • Time Frame: 5 years
      Safety Issue?: No

Secondary Measures

  • Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
    • Time Frame: 12 week posttreatment visit
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Graceway Pharmaceuticals, LLC
  • Provider of Information About this Clinical Study
    • Medical Director, Graceway Pharmaceuticals
  • Overall Official(s)
    • Jim Lee, Dr., Study Director, Graceway Pharmaceuticals

Citations Reporting on Results

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.

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.


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