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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01212562
Other study ID # 75090409
Secondary ID
Status Completed
Phase Phase 3
First received September 29, 2010
Last updated August 31, 2011
Start date April 2007
Est. completion date August 2011

Study information

Verified date August 2011
Source University of Ioannina
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date August 2011
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
Immunocryosurgery
Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin

Locations

Country Name City State
Greece Department for Skin and Venereal Diseases, University Hospital Ioannina

Sponsors (1)

Lead Sponsor Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Feasibility and Tolerability of Immunocryosurgery 1 month Yes
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