Basal Cell Carcinoma Clinical Trial
Official title:
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
The purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma 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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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