Clinical trial NCT00463359: 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: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma
curettage
Imiquimod
treatment
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
name: Glasgow Western Infirmary
First posted: 2007-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 49
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Basal Cell Carcinoma recurrence rates in 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Dermatology Department, Western Infirmary
state: Lanarkshire
Study officials:
affiliation: Western Infirmary
name: Lorna MacKintosh, Specialist Registrar
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Infirmary
name: Areti Makrygeorgou, Staff Grade Dr
role: STUDY_CHAIR
References: