4 Iconography
Access to the text (HTML) Access to the text (HTML)
PDF Access to the PDF text

Access to the full text of this article requires a subscription.
  • If you are a subscriber, please sign in 'My Account' at the top right of the screen.

  • If you want to subscribe to this journal, see our rates

Journal of the American Academy of Dermatology
Volume 57, n° 4
pages 616-621 (octobre 2007)
Doi : 10.1016/j.jaad.2007.05.022
accepted : 19 May 2007

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, MD a, Anne Kamin, MD a, Benjamin M. Weide, MD a, Helmut Breuninger, MD b, Ulrich M. Caroli, MD a, Matthias Möhrle, MD b, Peter Radny, MD a, c, Claus Garbe, MD a,
a Skin Cancer Program, Department of Dermatology, Eberhard-Karls-University, Tuebingen, Germany 
b Department of Dermatology, Eberhard-Karls-University, Tuebingen, Germany 
c Department of Dermatology, Albert-Ludwigs-University, Freiburg, Germany 

Reprint requests: Claus Garbe, MD, Professor of Dermatology, Head, Division of Dermatooncology, Department of Dermatology, Eberhard-Karls-University, Liebermeisterstrasse 25, D-72076 Tübingen, Germany.

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


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.


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.


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


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.

The full text of this article is available in PDF format.

 Supported by 3M Medica, Neuss, Germany.
 Conflicts of interest: None declared.

© 2007  American Academy of Dermatology, Inc.@@#104156@@
EM-CONSULTE.COM is registrered at the CNIL, déclaration n° 1286925.
As per the Law relating to information storage and personal integrity, you have the right to oppose (art 26 of that law), access (art 34 of that law) and rectify (art 36 of that law) your personal data. You may thus request that your data, should it be inaccurate, incomplete, unclear, outdated, not be used or stored, be corrected, clarified, updated or deleted.
Personal information regarding our website's visitors, including their identity, is confidential.
The owners of this website hereby guarantee to respect the legal confidentiality conditions, applicable in France, and not to disclose this data to third parties.
Article Outline