NCT01212562

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: University of Ioannina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Immunocryosurgery	Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-04-01
• Completion: 2011-08-01
• First posted: 2010-09-30
• Last updated: 2011-09-02

Locations

1 site across 1 country: Greece