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NCT Number: NCT01212562

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

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for Skin and Venereal Diseases, University Hospital

Ioannina, 45110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunocryosurgery

Procedure

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

Other names: Aldara

Primary outcomes

  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 outcomes

  1. Feasibility and Tolerability of Immunocryosurgery

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study 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

Acronym: IMCX

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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