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 Overview
=================
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.

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

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Imiquimod cream
* Procedure: curettage and cautery


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 49 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imiquimod cream|nan|
|Procedure: curettage and cautery|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal Cell Carcinoma recurrence rates in 3 years |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
basal cell carcinoma, curettage, Imiquimod, treatment