Trial Information

Open Label, Phase 3 Study of the Efficacy of Combination of Imiquimod and Cryosurgery in the Treatment of Primary Basal Cell Carcinomas of the Skin

Evaluation of efficacy:

- Number of patient: N=50

- Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy

- Exclusion criteria: (1) Size of the tumors >2cm; (2) Distance from the eyelid <1cm;
(3)Number of tumors >5

Treatment protocol: Patients will apply imiquimod daily for 14 days on the tumor and a rim
of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 10-15 seconds,
with open spray liquid nitrogen) will be applied and the patients will continue application
of imiquimod for another 3 weeks before being evaluated again. Persisting erosion will be
considered as persistence of the tumor and imiquimod will be continued for another 3 weeks
with/or without a cryosurgery session. The patients will be evaluated at 1,3,6,12 months
after discontinuation of imiquimod and yearly thereafter for relapse. In case of clinical
relapse, it will be confirmed by biopsy.