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Background Imiquimod has shown to be efficacious in basal cell carcinoma and actinic keratosis, but with therapeutic burden such as strong skin reactions and long treatment periods. Objectives To compare the safety and efficacy of different application frequencies of the new laser skin microporation device combined with topical 5% imiquimod and the standard use of imiquimod alone for the treatment of actinic keratosis and basal cell carcinomas. Methods In two prospective, randomised, dose finding, pilot studies for basal cell carcinoma and actinic keratosis, we used either imiquimod alone according to the approved dosage (control arm 1) or on microporated skin for 1x/2x/3x/week (arm 1-4), respectively. Strength of imiquimod-induced skin reactions at day 20 (study end) represented the primary endpoint. Secondary study parameters comprised the development and strength of skin erythema including crusting and erosions during the whole study, clearence at day 20 and tolerability as well as safety parameters. Results In both studies (patients/lesions treated and analysed: basal cell carcinoma 16/20 and 13/15; actinic keratosis 18/21 and 13/15) the combined laser and imiquimod therapy led to stronger skin erythema, crusting and erosion levels in the early study phase. Well tolerated without new safety signals, total clearence rates (arms 2-4/control arm 1) were 78%/75% (basal cell carcinoma) and 77%/50% (actinic keratosis), respectively. Conclusions We suggest to call this new treatment approach laser dynamic therapy. Based on our data, the most appropriate laser and imiquimod application frequency might be 2x/week (2-3 shots each at 3 pulses) with a suggested time to heal of 3 weeks. Further studies with larger patient cohorts are needed to substantiate our data. J O U R N A L O F D E R M A T O L O G I C A L R E S E A R C H A N D T H E R A P Y ISSN NO: 2471-2175 RESEARCH DOI : 10.14302/issn.2471-2175.jdrt-14-552 Corresponding Author: Robert Strohal, MD; Professor of Dermatology, Head of Dep. Dept. of Dermatology and Venereology; Federal Academic Teaching Hospital Feldkirch Carinagasse 45-47, 6800 Feldkirch; Austria Telephone: +43/5522/303.1200,-9121; Mobile: +43/664/1142140; Fax: +43/5522/303-7547 Robert.strohal@lkhf.at Running title: Skin microporation and imiquimod in actinic keratosis and basal cell carcinoma |
