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

This study is not yet open for participant recruitment.

Verified by University of Glasgow, April 2007

Sponsors and Collaborators:	University of Glasgow NHS Greater Clyde and Glasgow Glasgow Western Infirmary
Information provided by:	University of Glasgow
ClinicalTrials.gov Identifier:	NCT00463359

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

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by University of Glasgow:

Primary Outcome Measures:

Basal Cell Carcinoma recurrence rates in 3 years

Estimated Enrollment:

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

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, Lanarkshire
Dermatology Department, Western Infirmary
Glasgow, Lanarkshire, United Kingdom, G11 6NT

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

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

Keywords provided by University of Glasgow:

basal cell carcinoma
curettage
Imiquimod
treatment

Study placed in the following topic categories:

Facies
Interferons
Imiquimod

Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Neoplasms, Basal Cell
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009