Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Basal Cell Carcinoma	Procedure: Immunocryosurgery	Phase 3

Study Type:	Observational
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

Resource links provided by NLM:

Drug Information available for: Imiquimod

U.S. FDA Resources

Further study details as provided by University of Ioannina:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	April 2007
Study Completion Date:	August 2011
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Immunocryosurgery 2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application	Procedure: Immunocryosurgery Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin Other Name: Aldara

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with basal cell carcinoma

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212562

Locations

Greece
Department for Skin and Venereal Diseases, University Hospital
Ioannina, Greece, 45110

Sponsors and Collaborators

University of Ioannina

Investigators

Principal Investigator:

Ioannis D Bassukas, Professor

Medical School, University of Ioannina

More Information

Publications:

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. Epub 2009 Jun 25.

Bassukas ID, Gaitanis G. Combination of cryosurgery and topical imiquimod: does timing matter for successful immunocryosurgery? Cryobiology. 2009 Aug;59(1):116-7. 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.

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. No abstract available.

Responsible Party:	Ioannis Bassukas, Associate Professor of Dermatology, University of Ioannina
ClinicalTrials.gov Identifier:	NCT01212562 History of Changes
Other Study ID Numbers:	75090409
Study First Received:	September 29, 2010
Last Updated:	August 31, 2011
Health Authority:	Greece: Ethics Committee

Keywords provided by University of Ioannina:

basal cell carcinoma
cryosurgery
imiquimod
immunocryosurgery

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site

Skin Diseases
Neoplasms, Squamous Cell
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on June 17, 2013

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