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A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base

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ClinicalTrials.gov Identifier: NCT00463359
Recruitment Status : Unknown
Verified April 2007 by University of Glasgow.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2007
Last Update Posted : April 20, 2007
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.

Condition or disease Intervention/treatment
Basal Cell Carcinoma Drug: Imiquimod cream Procedure: curettage and cautery

Detailed Description:
Basal Cell Carcinomas (BCC) are the commonest form of skin cancer in the white population. The face is where they most frequently occur and the nodular BCCs are the commonest type. Curettage and cautery/electrodessication (C&C) has been an established way of management of nodular BCCs for years, being a simple surgical procedure readily performed in outpatient clinics with good aesthetic results and high cure rates. The purpose of this study is to determine recurrence rates of nodular BCCs on the face removed with C&C followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with C&C alone. Imiquimod is an immune response modifier with anti-tumour effects already licensed for the treatment of superficial BCCs in the UK.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double Curettage and Cautery Followed by Application of Imiquimod to the Base

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Basal Cell Carcinoma recurrence rates in 3 years

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Well-defined primary, not previously treated nodulo-cystic BCC
  • Size of the lesions: ≤ 1cm diameter
  • Facial lesions
  • Patient compliance competent
  • Patient physically able to apply the treatment (cream)

Exclusion Criteria:

  • Recurrent lesions
  • Superficial, morphoeic or pigmented BCC
  • Lesions close to vital structures; i.e. where C&C is not considered a standard treatment (eyelids, inner canthus, free borders)
  • Lesions within 1 cm of the eyelids, nose, lips and hairline
  • Immunosuppressed patients
  • Women in childbearing age, pregnancy and breast-feeding
  • Ages <50 or >90
  • Patients compliance incompetent
  • Patients physically incapable to apply the treatment (cream)
  • Patients with Gorlin Syndrome (nevoid Basal Cell Carcinoma syndrome)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00463359


Contacts
Contact: Robert Herd, Consultant Dermatologist +441412111000 ext 6259 robert.herd@northglasgow.scot.nhs.uk

Locations
United Kingdom
Dermatology Department, Western Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G11 6NT
Contact: Robert Herd, Consultant Dermatologist    +441412111000 ext 6259    robert.herd@northglasgow.scot.nhs.uk   
Contact: Areti Makrygeorgou, Staff Grade Dr    +441412111000 ext 2903    amakrygeorgou@hotmail.com   
Sub-Investigator: Areti Makrygeorgou, Staff Grade Dr         
Sub-Investigator: Robert Herd, Consultant Dermatologist         
Principal Investigator: Lorna MacKintosh, Specialist Registrar         
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde
Glasgow Western Infirmary
Investigators
Principal Investigator: Lorna MacKintosh, Specialist Registrar Western Infirmary
Study Chair: Areti Makrygeorgou, Staff Grade Dr Western Infirmary
More Information

ClinicalTrials.gov Identifier: NCT00463359     History of Changes
Other Study ID Numbers: WN07DE002
EudraCT No: 2007-001961-14
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007

Keywords provided by University of Glasgow:
basal cell carcinoma
curettage
Imiquimod
treatment

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