A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma.

Phase 3

Active, not recruiting

• Conditions: low risk superficial basal cell carcinoma; low risk nodular basal cell carcinoma; Skin - Dermatological conditions; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12611001083987
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

People with low risk superficial or nodular basal cell carcinoma (histologically proven basal cell carcinoma)

Exclusion Criteria

Genetic/nevoid conditions e.g. Gorlin's syndrome.
Morphoeic (microinfiltrative) trial lesion as diagnosed clinically.
Allergy to any of the interventions.
Involvement in a trial of another experimental intervention.
Life threatening disease.
Patients with bleeding disorders.
Patients not available for follow up for 3 yrs.
Pregnant, intention to become pregnant during treatment phase of the trial, or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of treatment failure or any signs of local recurrence at 3 years as judged by the consultant dermatologist (=success)[3 years]

Secondary Outcome Measures

Name	Time	Method
Absence of treatment failure or any signs of local recurrence as judged by the consultant dermatologist (=success)[1 year (clinical assessment), 2yrs (clinical assessment), 5yrs (from notes only)];Time to recurrence. This is worked out from the success assessments (primary outcome and secondary outcome 1).[Time to recurrence is in time intervals as assessments are only made at intervals (up to 1 year, 1-2years, 2-3years, 3-5 years, >5years); up to 3 years by clinical assessment, 3-5 years from patient notes (hospital, GP and pathology).];Aesthetic appearance of lesion site (as assessed by patient [5-point scale, excellent to very poor) and blinded assessor [5-point scale, as for participant, also features of appearance. Assessments made from photographs]).[Patient assessments made from month 6 on, blinded assessor at month 6 and year 3.]