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

Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00463359
• Other study ID #: WN07DE002
• Secondary ID: EudraCT No: 2007
• Status: Not yet recruiting
• Phase: N/A
• First received: April 19, 2007
• Last updated: April 19, 2007

Study information

• Verified date: April 2007
• Source: University of Glasgow
• Contact: Robert Herd, Consultant Dermatologist
• Phone: +441412111000
• Email: robert.herd[@]northglasgow.scot.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 49 Years to 89 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• Imiquimod cream

Procedure:
• curettage and cautery

Locations

Country	Name	City	State
United Kingdom	Dermatology Department, Western Infirmary	Glasgow	Lanarkshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Glasgow	Glasgow Western Infirmary, NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal Cell Carcinoma recurrence rates in 3 years