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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Procedure: Immunocryosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunocryosurgery<br>2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application | Procedure: Immunocryosurgery<br>* Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin<br>* Other names: Aldara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin | 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. | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and Tolerability of Immunocryosurgery |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery