Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen’s disease): A randomized, double-blind, placebo-controlled trial - 09/08/11
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 numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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