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Safety and Efficacy Study of Imiquimod 5% Cream Applied 3x Per Week for 8 or 12 Weeks in Low Risk Nodular Basal Cell Carcinoma

NCT00204555 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-09-01

No results posted yet for this study

Summary

Results from a pilot study demonstrated that topical imiquimod could clear superficial and nodular BCCs. Three phase II dose response studies in subjects with nodular BCC (nBCC) showed that the histological cure rates with imiquimod depend on the doses applied per week and the duration of treatment. Daily dosing or 5 times per week applications showed higher total clearance rates than 3 times per week dosing or less frequent dosing. Furthermore, a 12 week treatment period resulted in better efficacy results than a duration of only 6 weeks. On the other hand, local skin reactions increased with the doses applied per week. So a prolonged treatment period of 8 or 12 weeks with an application frequence of 3 times a week seems to be a good compromise between efficacy and safety.

Conditions

  • Carcinoma, Basal Cell

Interventions

DRUG

Imiquimod

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Claus Garbe, MD · Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Completion
2005-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00204555 on ClinicalTrials.gov