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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


N/A
49 Years
89 Years
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

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 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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Basal Cell Carcinoma recurrence rates in 3 years

Principal Investigator

Lorna MacKintosh, Specialist Registrar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western Infirmary

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

WN07DE002

NCT ID:

NCT00463359

Start Date:

Completion Date:

Related Keywords:

  • Basal Cell Carcinoma
  • basal cell carcinoma
  • curettage
  • Imiquimod
  • treatment
  • Carcinoma
  • Carcinoma, Basal Cell

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