{"registry": "ISRCTN", "registryId": "ISRCTN79701845", "source": "https://www.isrctn.com/ISRCTN79701845", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN79701845/format/default", "fetchedAt": "2026-10-07T17:01:21.878380Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Three non-invasive treatment options of superficial basal cell carcinoma", "scientificTitle": "Three non-invasive treatment options of superficial basal cell carcinoma: photodynamic therapy (PDT) vs imiquimod vs 5-fluorouracil: TTOP-sBCC trial", "acronym": "TTOP-sBCC", "hypothesis": "There is no significant difference in recurrence rate and cosmetic outcome between the three treatment options. There will be a significant difference in cost effectiveness, PDT is expected to be much more expensive than the other two treatment options.", "primaryOutcome": "1. Clearance rate 3 months after the end of interventions\n2. Recurrence rate 1 year after the end of interventions", "secondaryOutcome": "1. Cost effectiveness \n2. Patient preference, assessed by a questionnaire 1.5 years after the start of the study\n3. Compliance, assessed by a questionnaire based on items of the Brief Medication Questionnaire (ref: Svarstad BL et al. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient educ couns. 1999 Jun; 37(2): 113-24).\n4. Side effects (pain), assessed using a questionnaire during treatment\n5. Cosmetic outcome at 3 months and 1 year, assessed by both patient and one blinded medical doctor using the Patient and Observer scale (ref: Draaijers LJ et al. The patient and observer scare assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun; 113(7): 1960-5) and a 5-point scale.", "intervention": "\n\tArm 1: Photodynamic therapy with Metvix®, 2 times 37 J/cm^2 with one week between the two sessions. Lamp used: Omnilux PDT™, Waldmann PDT™ or Aktilite PDT™ (Galderma).\nArm 2: Imiquimod (Aldara®): 5/7 days, once a day for 6 weeks \nArm 3: 5-fluorouracil (Efudix®): 7/7 days, two times a day for 4 weeks \n\nFollow up: 3 months-12 months (-2 years-3 years-4 years-5 years)\n\tDrug\n\tNot Applicable\n\tImiquimod, 5-fluorouracil.\n      ", "condition": "\n\tSuperficial basal cell carcinoma\n\tCancer\n\tOther malignant neoplasms of skin\n      ", "studyDesign": "Randomised single-blind multi-centre trial", "overallEndDate": "2011-03-01T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2019-03-14T11:27:22.737Z", "eligibility": {"inclusion": "1. Primary histologically proven superficial basal cell carcinoma of the skin \n2. Age 18-80 years \n3. Both men and women", "exclusion": "1. Genetic skin malignancies\n2. Tumour location: peri-ocular, auricular, nasal, hairy scalp\n3. Pregnancy\n4. Treatment with systemic immunosuppression therapy", "ageRange": "Adult", "gender": "Not Specified", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2008-03-01T00:00:00.000Z", "recruitmentEnd": "2011-03-01T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "600", "totalFinalEnrolment": "601"}, "countries": ["Netherlands"], "locations": [{"name": "P.Debyelaan 25", "city": "Maastricht", "state": "", "country": "Netherlands", "zip": "6202 AZ"}], "sponsors": [{"organisation": "The Netherlands Organisation for Health Research and Development (ZonMw)", "sponsorType": "Research organisation", "rorId": "https://ror.org/01yaj9a77"}], "funders": [{"name": "The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)"}]}, "studySha256": "1ba169ff5d92ff968cb9d5854f1172681d3e489e13f8a44081eb114828e4b466"}