Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery
NCT ID: NCT01212562
Last Updated: 2011-09-02
Study Results
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Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2007-04-30
2011-08-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Immunocryosurgery
2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application
Immunocryosurgery
Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin
Interventions
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Immunocryosurgery
Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Size \< or = 2cm
* Number of tumors \< or = 5
* Distance from eyelids, mouth \>1cm
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Ioannina
OTHER
Responsible Party
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Ioannis Bassukas
Associate Professor of Dermatology
Principal Investigators
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Ioannis D Bassukas, Professor
Role: PRINCIPAL_INVESTIGATOR
Medical School, University of Ioannina
Locations
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Department for Skin and Venereal Diseases, University Hospital
Ioannina, , Greece
Countries
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References
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Bassukas ID, Gaitanis G. Combination of cryosurgery and topical imiquimod: does timing matter for successful immunocryosurgery? Cryobiology. 2009 Aug;59(1):116-7. doi: 10.1016/j.cryobiol.2009.04.011. Epub 2009 May 6. No abstract available.
Bassukas ID, Gamvroulia C, Zioga A, Nomikos K, Fotika C. Cryosurgery during topical imiquimod: a successful combination modality for lentigo maligna. Int J Dermatol. 2008 May;47(5):519-21. doi: 10.1111/j.1365-4632.2008.03562.x.
Gaitanis G, Mitsou G, Tsiouri G, Alexis I, Bassukas ID. Cryosurgery during imiquimod cream treatment ("immunocryosurgery") for Bowen's disease of the skin: a case series. Acta Derm Venereol. 2010 Sep;90(5):533-4. doi: 10.2340/00015555-0896. No abstract available.
Gaitanis G, Nomikos K, Vava E, Alexopoulos EC, Bassukas ID. Immunocryosurgery for basal cell carcinoma: results of a pilot, prospective, open-label study of cryosurgery during continued imiquimod application. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1427-31. doi: 10.1111/j.1468-3083.2009.03224.x. Epub 2009 Jun 25.
Gaitanis G, Bassukas ID. Immunocryosurgery for non-superficial basal cell carcinomas </= 20 mm in maximal diameter: Five-year follow-up. J Geriatr Oncol. 2019 May;10(3):475-478. doi: 10.1016/j.jgo.2018.08.012. Epub 2018 Sep 12.
Other Identifiers
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75090409
Identifier Type: -
Identifier Source: org_study_id
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