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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212562
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : September 2, 2011
Information provided by (Responsible Party):
Ioannis Bassukas, 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Procedure: Immunocryosurgery Phase 3

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 Type : Observational
Estimated Enrollment : 70 participants
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
Study Start Date : April 2007
Primary Completion Date : April 2010
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin [ Time Frame: 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 :
  1. Feasibility and Tolerability of Immunocryosurgery [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Blood samples with anticoagulant at -20C

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with basal cell carcinoma

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212562

Department for Skin and Venereal Diseases, University Hospital
Ioannina, Greece, 45110
Sponsors and Collaborators
University of Ioannina
Principal Investigator: Ioannis D Bassukas, Professor Medical School, University of Ioannina

Publications of Results:
Other Publications:
Responsible Party: Ioannis Bassukas, Associate Professor of Dermatology, University of Ioannina Identifier: NCT01212562     History of Changes
Other Study ID Numbers: 75090409
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

Keywords provided by Ioannis Bassukas, University of Ioannina:
basal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers