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

Completed

• Conditions: Basal Cell Carcinoma
• Interventions: Procedure: Immunocryosurgery

• Registration Number: NCT01212562
• Lead Sponsor: University of Ioannina

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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2010-04
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Status Verified: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Basal cell carcinoma of the skin
• Size < or = 2cm
• Number of tumors < or = 5
• Distance from eyelids, mouth >1cm

Exclusion Criteria

• Size >2cm Number of tumors > 5 Distance from eyelids or mouth < or = 1cm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunocryosurgery	Immunocryosurgery	2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application

Primary Outcome Measures

Name	Time	Method
Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin	1 months	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility and Tolerability of Immunocryosurgery	1 month

Trial Locations

Locations (1)

Department for Skin and Venereal Diseases, University Hospital; 🇬🇷 Ioannina, Greece