Status:

COMPLETED

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

Lead Sponsor:

Graceway Pharmaceuticals, LLC

Conditions:

Superficial Basal Cell Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 t...

Eligibility Criteria

Inclusion

  • 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

  • Evidence of clinically significant, unstable medical conditions
  • Cannot have recent use of topical steroids or retinoids in the treatment area.

Key Trial Info

Start Date :

March 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2007

Estimated Enrollment :

169 Patients enrolled

Trial Details

Trial ID

NCT00189306

Start Date

March 1 2001

End Date

April 1 2007

Last Update

August 10 2010

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Medical Centre, Concord Hospital

Concord, New South Wales, Australia

2

Prince of Wales Hospital

Randwick, New South Wales, Australia

3

Skin Centre

Benowa, Queensland, Australia

4

South East Dermatology Centre

Carina Heights, Queensland, Australia