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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University of Glasgow.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
NHS Greater Clyde and Glasgow
Glasgow Western Infirmary
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00463359
First received: April 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention
Basal Cell Carcinoma
Drug: Imiquimod cream
Procedure: curettage and cautery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 NLM:


Further study details as provided by University of Glasgow:

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

Estimated Enrollment: 50
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.

  Eligibility

Ages Eligible for Study:   49 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Clyde and Glasgow
Glasgow Western Infirmary
Investigators
Principal Investigator: Lorna MacKintosh, Specialist Registrar Western Infirmary
Study Chair: Areti Makrygeorgou, Staff Grade Dr Western Infirmary
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463359     History of Changes
Other Study ID Numbers: WN07DE002, EudraCT No: 2007-001961-14
Study First Received: April 19, 2007
Last Updated: April 19, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on July 28, 2014