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.

Confirmation of histological clearance of superficial basal cell carcinoma with multiple serial sectioning and Mohs' micrographic surgery following treatment with imiquimod 5% cream.

BACKGROUND: Although the effectiveness of daily dosing regimens of 5% imiquimod cream for the treatment of superficial basal cell carcinomas (sBCC) has been documented by recent studies, concerns about long-term outcome remain. The majority of efficacy data is based on clinical clearance and limited histological examination which may not identify tumour presence at the periphery. OBJECTIVE: To assess the efficacy of 5% imiquimod cream for sBCC using detailed histological assessment 1 year after completion of treatment. METHODS: Nine individuals with biopsy-proven sBCC treated with 5% imiquimod cream 1 year previously and who remained clinically clear were recruited. Paraffin-embedded excision specimens from the original tumour site were extensively examined by a dermatopathologist. Examination and analysis of frozen sections of the original tumour perimeter using Mohs' micrographic surgery (MMS) were then performed. RESULTS: Eight of nine individuals, 89% (95% CI 56% to 97%) were histologically clear of sBCC at 52 weeks. One individual had a single focus of sBCC at one lateral margin. CONCLUSION: The results show agreement between the clinical and histological assessment of tumour clearance. However, the persistence of disease in one patient, although limited, indicates the need for cautious long-term follow-up studies on the use of 5% imiquimod cream for sBCC.

Painful spitz naevus sole of foot.

A 21-year-old student of sports science presented with a 12-month history of a painful nodule on the sole of her left foot, which severely constrained her sporting activities. She was otherwise well. On examination there was a bluish pink 7-mm nodule on the arch of her left foot (Fig. 1). It was firm, exquisitely tender and she walked with a slight limp. The lesion was curetted and sent for histological diagnosis. The specimen showed a symmetrical wedge-shaped compound melanocytic lesion reaching the margins of the biopsy. The overlying epidermis was acanthotic and hyperkeratotic. Junctional nests were present and there was clefting between them and the epidermis (Fig. 2). Near the nests were eosinophilic globules (Kamino bodies) and pigment-laden macrophages. The lesion consisted of a mixture of large spindle and epithelioid cells with abundant eosinophilic cytoplasm and plump nuclei with prominent nucleoli. There were a few mitoses but none was atypical. Single epithelioid melanocytes were present deep within the lesion (outlier cells) and there was maturation with depth in the dermis. The histological features were those of Spitz naevus. There was significant reduction in the severity of her pain after curettage but the pain subsequently recurred. In view of this and possible incomplete excision, the scar was re-excised with a narrow margin. Histology confirmed complete excision of the residual naevus. Her symptoms have since subsided.