Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery (IMCX)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]Basal cell carcinomas of the skin will be treated with immunocryosurgery and the efficacy will be measured 1, 3, 6, and 12 months. Reappearance of the tumor within the primary lesion and 1cm around it will be considered as relapse.
- Feasibility and Tolerability of Immunocryosurgery [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Blood samples with anticoagulant at -20C
|Study Start Date:||April 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application
Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin
Other Name: Aldara
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212562
|Department for Skin and Venereal Diseases, University Hospital|
|Ioannina, Greece, 45110|
|Principal Investigator:||Ioannis D Bassukas, Professor||Medical School, University of Ioannina|