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

NCT01212562 | Completed DMC

• 1 other identifier: 75090409
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma; cryosurgery; imiquimod; immunocryosurgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Feasibility and Tolerability of Immunocryosurgery

  1 month

Study Arms (1)

Immunocryosurgery

2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application

Procedure: Immunocryosurgery

Interventions

Immunocryosurgery PROCEDURE

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

Also known as: Aldara

Immunocryosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with basal cell carcinoma

You may qualify if:

• Basal cell carcinoma of the skin
• Size \< or = 2cm
• Number of tumors \< or = 5
• Distance from eyelids, mouth \>1cm

You may not qualify if:

• Size \>2cm Number of tumors \> 5 Distance from eyelids or mouth \< or = 1cm

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Department for Skin and Venereal Diseases, University Hospital

Ioannina, 45110, Greece

Location

Related Publications (5)

• 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.

  PMID: 19426725 BACKGROUND

• 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.

  PMID: 18412875 BACKGROUND

• 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.

  PMID: 20814639 BACKGROUND

• 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.

  PMID: 19555364 RESULT

• 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.

  PMID: 30219274 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with anticoagulant at -20C

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ioannis D Bassukas, Professor

  Medical School, University of Ioannina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: April 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2011
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

GR (1)