Clinical trial · Interventional
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
A Randomized Controlled Trial of Excisional Surgery Versus Imiquimod 5% Cream for Nodular and Superficial Basal Cell Carcinoma
NCT00066872CI-TRIAL-00012149completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer. PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-melanomatous Skin Cancer | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Absence of local recurrence at 3 years after start of treatment
Secondary outcomes (5)
- measure
- Recurrence of basal cell cancer (BCC) at 1, 2, and 5 years
- measure
- Time to first occurrence up to 5 years from completion of study treatment
- measure
- Aesthetic appearance of lesion site as measured by participant and blind observer using 5-point Likert scale at 6 months, and then years 1-3
- measure
- Pain at lesion site as measured by 6-point scale daily during treatment, and then 16 weeks after the completion of study treatment
- measure
- Cost effectiveness assessed up to 3 or 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary basal cell skin carcinoma * Nodular or superficial lesion(s)\* * Located in low-risk areas NOTE: \*Any number of lesions are allowed but only 1 lesion per patient is selected for the study * No genetic or nevoid conditions (e.g., Gorlin's syndrome) * No morphoeic (microinfiltrative) histology PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * No bleeding disorder Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 1 month after study participation * No allergy to any of the study interventions * No life-threatening disease * Must be available for study follow-up for up to 3 years * Must have access to a telephone PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No concurrent participation in any other experimental trial
References
Publications (3)
- RESULTOzolins M, Williams HC, Armstrong SJ, Bath-Hextall FJ. The SINS trial: a randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma. Trials. 2010 Apr 21;11:42. doi: 10.1186/1745-6215-11-42. PMID 20409337
- DERIVEDWilliams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5. PMID 27932240
- DERIVEDBath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PS, Williams HC; Surgery versus Imiquimod for Nodular Superficial basal cell carcinoma (SINS) study group. Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jan;15(1):96-105. doi: 10.1016/S1470-2045(13)70530-8. Epub 2013 Dec 11. PMID 24332516