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

University of Glasgow

Status: Unknown

Conditions: Basal Cell Carcinoma

Treatments: Procedure: curettage and cautery; Drug: Imiquimod cream

Study type: Interventional

Funder types: Other

Identifiers

NCT00463359

WN07DE002

EudraCT No: 2007-001961-14

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 49 to 89 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)