Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen’s disease): A randomized, double-blind, placebo-controlled trial - 09/08/11
, Richard Goodwin, MBBS, MRCP a, Maureen Chawla, BA, RGN b, Peter Laidler, BM, BCh, DM, FRCPath c, Patricia E. Price, BA(Hons), AFBPsS, CHPsychol PhD d, Andrew Y. Finlay, MBBS, FRCP b, Richard J. Motley, B Chir, BA, MA, MB, FRCP, MD a
Reprint requests: Girish K. Patel, Welsh Institute of Dermatology, University Hospital of Wales, University Hospital of Wales and Llandough Hospital National Health Service Trust, Heath Park, Cardiff CF14 4XW, United Kingdom.Cardiff, United Kingdom
Abstract |
Background |
We conducted a double-blind, placebo-controlled, randomized trial to evaluate the preliminary efficacy and safety of imiquimod 5% cream treatment for cutaneous squamous cell carcinoma (SCC) in situ.
Methods |
In all, 31 patients with biopsy-proven cutaneous SCC in situ were randomly assigned to placebo (vehicle) (n = 16) or imiquimod 5% cream (n = 15) daily for 16 weeks. Patients were assessed at week 28 for the primary end point, resolution of cutaneous SCC in situ.
Results |
Of the 31 patients enrolled, 3 dropped out. Intention-to-treat analysis revealed 11 of the 15 patients (73%) in the imiquimod group achieved resolution of cutaneous SCC in situ, with no relapse during the 9-month follow-up period; none in the placebo group achieved resolution (P < .001). Imiquimod 5% cream was generally well tolerated and there were no serious adverse events.
Limitations |
Topical imiquimod 5% cream has proven to be an effective treatment for cutaneous SCC in situ. However, studies to define the ideal dosing regimen and cost-effectiveness are required before it can be accepted as a recognized therapy.
Conclusions |
In this controlled trial, patients with cutaneous SCC in situ receiving topical imiquimod 5% cream as monotherapy experienced a high degree of clinical benefit compared with placebo.
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| Supported by 3M Healthcare Ltd as an unrestricted research grant, with approval from the Medicines Control Agency. Conflicts of interest: None identified. Presented at Young Investigators Symposium of the 62nd Annual Meeting of the American Academy of Dermatology, Washington DC, February 11, 2004. (Dr Patel). |
Vol 54 - N° 6
P. 1025-1032 - juin 2006 Retour au numéro
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