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

Tracking Information

First Received Date ^ICMJE

April 19, 2007

Last Updated Date

April 19, 2007

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Basal Cell Carcinoma recurrence rates in 3 years

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Basal Cell Carcinoma

Intervention ^ICMJE

Drug: Imiquimod cream
Procedure: curettage and cautery

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

49 Years to 89 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Robert Herd, Consultant Dermatologist

+441412111000 ext 6259

robert.herd@northglasgow.scot.nhs.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00463359

Other Study ID Numbers ^ICMJE

WN07DE002, EudraCT No: 2007-001961-14

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Glasgow

Collaborators ^ICMJE

NHS Greater Clyde and Glasgow
Glasgow Western Infirmary

Investigators ^ICMJE

Principal Investigator:	Lorna MacKintosh, Specialist Registrar	Western Infirmary
Study Chair:	Areti Makrygeorgou, Staff Grade Dr	Western Infirmary

Information Provided By

University of Glasgow

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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