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OpenTrials
Completed

NCT Number: NCT00189306

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

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.

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Key information

Conditions

Superficial Basal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Centre, Concord Hospital, Concord, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imiquimod 5% Cream

Drug

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

Other names: Aldara (imiquimod) 5% cream - 250 mg / packet

Primary outcomes

  1. Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)

    Time frame: 5 years

    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.

Secondary outcomes

  1. Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks

    Time frame: 12 week posttreatment visit

    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)

Sponsors and collaborators

Lead sponsor

Graceway Pharmaceuticals, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Aug 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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