Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2007 Oct;57(4):616-21.
doi: 10.1016/j.jaad.2007.05.022. Epub 2007 Jul 3.

A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma

Thomas K Eigentler  1 , Anne Kamin, Benjamin M Weide, Helmut Breuninger, Ulrich M Caroli, Matthias Möhrle, Peter Radny, Claus Garbe
Affiliations
Clinical Trial

A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma

Thomas K Eigentler et al. J Am Acad Dermatol. 2007 Oct.

Abstract

Objective: The present study was planned to evaluate the efficacy and tolerability of topical treatment with imiquimod in nodular basal cell carcinoma (nBCC).

Methods: One hundred two patients were randomized to receive thrice-weekly topical imiquimod for either 8 or 12 weeks. Twelve patients dropped out. A total of 90 patients were evaluated for tolerability and efficacy. Histologic clearance was controlled by excising the original tumor location with 3-mm margins and evaluating with permanent sections the cut-surgical margin, including the deep margin, and with serial step-sectioning the central portion of the tissue for tumor persistence.

Results: There were no significant differences between the treatment arms with respect to efficacy and tolerability. Of 90 evaluable patients, 70 had a complete clinical clearance (78%). Clinically visible tumor was still present in 20 patients (22%). A complete histopathological clearance was observed in 58 patients (64%). Tumor persisted in 32 patients (36%). In 12 patients, despite complete clinical clearance, tumor remnants were still detected in histopathological evaluation. Efficacy was better in nBCC that was less than 1 cm in diameter, showing 82% clinical and 72% histopathologic clearing. Adverse events were reported in 92% of the patients and were mainly classified as minor or moderate local inflammation.

Limitations: Clinical follow-up was limited to the time period between end of treatment and final complete excision.

Conclusion: Imiquimod applied thrice weekly for 8 and 12 weeks shows modest activity against small nBCC. Residual tumor was present in more than one third of treated patients. Clinical appearance after treatment does not accurately reflect the presence or absence of disease in nearly 1 of every 5 patients with nBCC. Since 17% of patients with clinical clearance still have pathologic evidence of disease, excisional biopsy of the treated site is still indicated.

PubMed Disclaimer

Publication types