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; MedDRA version: 9.1Level: LLTClassification code 10004146Term: Basal cell carcinoma

• Registration Number: EUCTR2007-001961-14-GB
• Lead Sponsor: Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary end point of the trial will be the treatment of the basal cell carcinoma. At first this will be removed with curettage and cautery and then application of the Imiquimod cream on the residual scar will follow.;Main Objective: To determine recurrence rates of Basal Cell Carcinomas (BCC) managed with double curettage and cautery (C&C) followed by additional application of Imiquimod cream on the residual scar.;Secondary Objective: To achieve lower recurrence rates of BCCs treated with double curettage and cautery (C&C) and additional Imiquimod cream compared with BCCs treated with C&C alone.