Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT02242929
• Date of registration: 15/09/2014
• Prospective Registration: Yes
• Primary sponsor: Maastricht University Medical Center
• Public title: Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma SCIN
• Scientific title: Surgical Excision Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma: an Open, Non-inferiority, Randomized Controlled Trial
• Date of first enrolment: January 2016
• Target sample size: 145
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02242929
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Klara Mosterd, MD, PhD
• Affiliation: Maastricht University Medical Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults aged 18 years or older

- Primary histologically proven nodular BCC = 4mm and = 20mm in diameter. (If the tumour
exhibits additional sBCC characteristics, but also contains nodular component that
extend into the reticular dermis, the tumour will be classified as nBCC with
superficial components and will be included).

- Comorbidities may not interfere with study treatment

- Capable to understand instructions

Exclusion Criteria:

- A nodular BCC located in the H-zone of the face or hairy scalp

- Recurrent (previously treated) nBCC

- Aggressive BCC subtypes (morphoea, micronodular, or BCC with squamous differentiation)

- Life expectancy of less than five years

- Breast-feeding or pregnant women

- Serious comorbidities

- Use of immunosuppressive medication during the trial period or within 30 days before
enrolment

- Patients with genetic skin cancer disorders



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Nodular Basal Cell Carcinoma

Intervention(s)

Procedure: Standard surgical excision

Drug: Imiquimod 5% cream with prior curettage

Primary Outcome(s)

Proportion of participants tumour-free [Time Frame: At 1 year after end of treatment]

Secondary Outcome(s)

Cosmetic appearance [Time Frame: At 1 and 5 year after end of treatment]

Cost-effectiveness [Time Frame: At 5 year after end of treatment]

Level of Pain [Time Frame: 2 weeks after end of treatment]

Adverse events [Time Frame: Up to 3 months after end of treatment]

Compliance [Time Frame: At 3 months after end of treatment]

The 5-year cumulative probability of recurrence free survival after end of treatment [Time Frame: At 5 years after end of treatment]

Patient satisfaction [Time Frame: At 1 and 5 year after end of treatment]

Secondary ID(s)

NL50433.068.14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors