Plain English Summary
A randomised controlled trial of the effectiveness of excisional surgery versus imiquimod 5% cream for long-term clinical success rate in patients with nodular and superficial basal cell carcinoma
1. Can imiquimod 5% cream applied topically give an acceptable and clinically useful success rate (3 year clinical clearance) and acceptable side effect profile when compared with excision surgery for superficial and nodular basal cell carcinoma (BCC) at low risk sites?
2. Is imiquimod more cost effective than surgery for low-risk BCC?
3. Does imiquimod result in a more aesthetically acceptable result than conventional excision?
4. Do certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment?
Queen's Medical Centre, Nottingham (now Nottingham Research Ethics Committee 2), 15/11/2001, ref: LREC:DE090101
Randomised interventional multicentre treatment trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Skin
Simple excisional surgery with a 4 mm margin versus imiquimod 5% cream (Aldara) applied once daily for 6 weeks for superficial BCC and 12 weeks for nodular BCC.
Follow Up Length: 36 months (60 months from records)
Study Entry: Single Randomisation only
Last patient recruited: 22/02/2007
Imiquimod 5% cream
Primary outcome measure
Clinical evidence of success (absence of any signs of local recurrence) at 3 years
Secondary outcome measures
1. Recurrence at 1, 2 and 5 years
2.Time to first recurrence
3. Aesthetic appearance of lesion site
4. Daily pain during and for 16 weeks post-treatment
5. Cost effectiveness
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Primary nodular or superficial basal cell carcinoma located in low risk area
2. Access to telephone
3. Histologically proven BCC
Male or female participants of any age were recruited.
Target number of participants
Planned sample size: 500; Actual sample size: 501
Participant exclusion criteria
1. Genetic or nevoid conditions e.g., Gorlin's syndrome
2. Morphoeic (microinfiltrative) as diagnosed clinically
3. Allergy to any of the interventions
4. Involvement in a trial of another experimental intervention
5. Life threatening disease
6. Bleeding disorders
7. Unavailable for 3 years follow-up
8. Pregnant or breastfeeding
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Centre of Evidence Based Dermatology
Cancer Research UK (CRUK) (UK) (ref: C7484/A2869; C7484/A8991)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Ozolins 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, 11, 42, doi: 10.1186/1745-6215-11-42.
Tinelli M, Ozolins M, Bath-Hextall F, Williams HC, What determines patient preferences for treating low risk basal cell carcinoma when comparing surgery vs imiquimod? A discrete choice experiment survey from the SINS trial., BMC Dermatol., 2012, 12, 19, doi: 10.1186/1471-5945-12-19.
Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PS, Williams HC, , Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial., Lancet Oncol., 2014, 15, 1, 96-105, doi: 10.1016/S1470-2045(13)70530-8.