Spots Global Cancer Trial Database for Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery

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Trial Identification

Brief Title: Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery

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

Study ID: NCT01212562

Conditions

Basal Cell Carcinoma

Interventions

Immunocryosurgery

Study Description

Brief Summary: 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.

Detailed Description: 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.