Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen's disease): A randomized, double-blind, placebo-controlled trial

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Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen's disease): A randomized, double-blind, placebo-controlled trial Girish K. Patel, MBBS, MRCP, MD, Richard Goodwin, MBBS, MRCP, Maureen Chawla, BA, RGN, Peter Laidler, BM, BCh, DM, FRCPath, Patricia E. Price, BA(Hons), AFBPsS, CHPsychol PhD, Andrew Y. Finlay, MBBS, FRCP, Richard J. Motley, B Chir, BA, MA, MB, FRCP, MD Journal of the American Academy of Dermatology Volume 54, Issue 6, Pages 1025-1032 (June 2006) DOI: 10.1016/j.jaad.2006.01.055 Copyright © 2006 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Trial profile. SCC, Squamous cell carcinoma. Journal of the American Academy of Dermatology 2006 54, 1025-1032DOI: (10.1016/j.jaad.2006.01.055) Copyright © 2006 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Clinical and histologic improvement in cutaneous squamous cell carcinoma (SCC) in situ with imiquimod 5% cream. Typical appearance of cutaneous SCC in situ (A), which is characterized histologically by full-thickness epidermal dysplasia (B). Same lesion was treated with topical imiquimod daily for 16 weeks. Assessment at week 28 revealed faint postinflammatory hyperpigmentation (C) and normal skin histology (D) with presence of granular layer and basket-weave stratum corneum. Journal of the American Academy of Dermatology 2006 54, 1025-1032DOI: (10.1016/j.jaad.2006.01.055) Copyright © 2006 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Treatment often caused inflammatory reaction at site of lesion. Almost all patients treated with imiquimod developed localized inflammatory reaction between weeks 4 and 12, which spontaneously resolved on stopping treatment. Most patients had erythema and mild transient pruritus or swelling and weeping (A, B, and C). Severe reaction was observed in 3 patients; two were withdrawn and the most severe completed the study (D, E, and F). Patient had biopsy-proven cutaneous squamous cell carcinoma (SCC) in situ surrounding radiotherapy scar from previously treated SCC (D). He later admitted to also applying imiquimod over forehead. He began to notice irritation after 6 weeks. Reaction was maximal at week 8 (E), and stopping treatment led to resolution by week 9. Completion of treatment led to complete clinical and histologic resolution, with no recurrence evident at week 52 (F). Journal of the American Academy of Dermatology 2006 54, 1025-1032DOI: (10.1016/j.jaad.2006.01.055) Copyright © 2006 American Academy of Dermatology, Inc. Terms and Conditions