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A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma
ISRCTN ISRCTN48755084
DOI 10.1186/ISRCTN48755084
ClinicalTrials.gov identifier NCT00066872
EudraCT number 2004-004506-24
Public title A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma
Scientific title 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
Acronym SINS
Serial number at source 1066
Study hypothesis 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?
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-treatment-for-basal-cell-skin-cancer
Ethics approval Queen’s Medical Centre, Nottingham (now Nottingham Research Ethics Committee 2) approved on the 15th November 2001 (ref: LREC:DE090101)
Study design Randomised interventional multicentre treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Skin
Participants - 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.
Participants - 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
Anticipated start date 19/06/2003
Anticipated end date 23/04/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned sample size: 500; Actual sample size: 501
Interventions 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
Primary outcome measure(s) Clinical evidence of success (absence of any signs of local recurrence) at 3 years
Secondary outcome measure(s) 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
Sources of funding Cancer Research UK (CRUK) (UK) (ref: C7484/A2869; C7484/A8991)
Trial website
Publications 1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20409337
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23035730
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24332516
Contact name Ms  Mara  Ozolins
  Address Centre of Evidence Based Dermatology
King’s Meadow Campus
Lenton Lane
  City/town Nottingham
  Zip/Postcode NG7 2NR
  Country United Kingdom
Sponsor University of Nottingham (UK)
  Address University Park
  City/town Nottingham
  Zip/Postcode NG7 2RD
  Country United Kingdom
  Email Paul.Cartledge@Nottingham.ac.uk
  Sponsor website: http://www.nottingham.ac.uk/
Date applied 31/03/2010
Last edited 28/02/2014
Date ISRCTN assigned 31/03/2010
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