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document
A randomized parallel study to assess the safety and efficacy of two different dosing regimens of 5 % imiquimod in the treatment of superficial basal cell carcinoma . OBJECTIVES This study was designed to compare the safety and efficacy of two cycled dosing regimens of imiquimod 5 % cream for treatment of superficial basal cell carcinoma ( sBCC ) . METHODS Patients ( n = 32 ) were randomized to receive one of two treatment regimens : 8 weeks of treatment with once-daily dosing for alternate weeks ( R1 ) and 5 weeks of once-daily dosing with a 1-week interval in the middle of the course ( R2 ) . Efficacy measures were tumour clearance at weeks 19 and 52 and measures of patients ' acceptability . RESULTS Data from 30 patients ( 13 females ) , 14 on R1 and 16 on R2 , were analysed . The results revealed an initial clearance rate of 64 % at week 19 for R1 and 81 % for R2 ( 95 % CI for difference : -14 % to 45 % , p = 0.21 ) . However , clearance rates at week 52 were significantly different : 43 % for R1 and 88 % for R2 ( 95 % CI for difference : 11 % to 68 % , p = 0.02 ) . There was no difference in acceptability of treatment as measured by composite median visual analogue scores at week 8 . CONCLUSION Five weeks of 5 % imiquimod cream once daily with a 1-week interval was more effective but as well tolerated as the 8-week alternate week regimen for sBCC .
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Intervention_Pharmacological
imiquimod
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Intervention_Pharmacological
imiquimod
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Intervention_Pharmacological
8 weeks of treatment with once-daily dosing for alternate weeks ( R1 )
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Intervention_Pharmacological
5 weeks of once-daily dosing with a 1-week interval in the middle of the course
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Intervention_Pharmacological
imiquimod
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Outcome_Other
safety and efficacy
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Outcome_Other
safety and efficacy
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Outcome_Physical
tumour clearance
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Outcome_Other
measures of patients ' acceptability
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Outcome_Physical
clearance rate
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Outcome_Physical
clearance rates
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Outcome_Other
acceptability of treatment
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Outcome_Other
effective
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Outcome_Other
well tolerated