NCT01212549

Brief Summary

To compare the effectiveness of two application schemes of cryosurgery during a 5 week course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks of topical imiquimod (cryoimmunotherapy)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

11 months

First QC Date

September 29, 2010

Last Update Submit

August 31, 2011

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinomacryosurgeryimiquimodimmunocryosurgery

Outcome Measures

Primary Outcomes (1)

  • Comparison of the efficacy of immunocryosurgery and cryoimmunotherapy

    1 month

Study Arms (2)

Immunocryosurgery

ACTIVE COMPARATOR

2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 weeks imiquimod

Procedure: Immunocryosurgery

Cryoimmunotherapy

ACTIVE COMPARATOR

Cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 5 weeks imiquimod

Procedure: Cryoimmunotherapy

Interventions

ImmunocryosurgeryPROCEDURE

2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod

Immunocryosurgery
CryoimmunotherapyPROCEDURE

Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod

Cryoimmunotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven basal cell carcinoma of the skin
  • Size \<5cm
  • Number of tumors \<5 cm
  • Distance from eyelids, mouth 0,5cm

You may not qualify if:

  • Size \>5cm
  • Number of tumors \> or =5
  • Distance from eyelids or mouth \< or =0.5cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Skin and Venereal Diseases, University Hospital

Ioannina, 45110, Greece

Location

Related Publications (4)

  • 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: 19555364BACKGROUND

  • 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: 19426725BACKGROUND

  • 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: 18412875BACKGROUND

  • 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: 20814639BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Ioannis D Bassukas, Professor

    Medical School, University of Ioannina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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

February 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations

GR(1)