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.
OBJECTIVE
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.


CONCLUSIONS
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.
Ezughah
Francesca I
FI
Department of Dermatology and Photobiology, Ninewells Hospital, Dundee, UK.
Dawe
Robert S
RS
Ibbotson
Sally H
SH
Fleming
Colin J
CJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod