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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

Not Applicable
Conditions
Basal Cell Carcinoma
Registration Number
NCT00463359
Lead Sponsor
University of Glasgow
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Basal Cell Carcinoma recurrence rates in 3 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dermatology Department, Western Infirmary

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Glasgow, Lanarkshire, United Kingdom

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