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Treatment of large nodular facial BCC with imiquimod 5% cream before Mohs micrographic surgery.


- candidate number2787
- NTR NumberNTR1081
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-okt-2007
- Secondary IDsM07-1745 METC Catharina Ziekenhuis Eindhoven
- Public TitleTreatment of large nodular facial BCC with imiquimod 5% cream before Mohs micrographic surgery.
- Scientific TitleProspective Randomised study on imiquimod 5% cream as pretreatment of Mohs micrographic surgery for primary large nodular basal cell carcinoma in the face to reduce the post-Mohs defect size.
- ACRONYMN/A
- hypothesisPretreatment with imiquimod 5% cream will decrease the defect after Mohs micrographic surgery by decreasing the size of the basal cell carcinoma. And will thereby improve cosmetic outcome.
- Healt Condition(s) or Problem(s) studiedBasal cell carcinoma
- Inclusion criteria1. Patients > 18 years;
2. Primary BCC, nodular or nodular and partially superficial;
3. BCC in the face;
4. BCC size 1-5 cm in diameter.
- Exclusion criteria1. Pregnant women;
2. Women who breastfeed;
3. Recurrent BCC;
4. Agressive growth pattern (squamous, morpheaform, infiltrative);
5. BCC within 1 cm from the eyes, lips or mucosa of the nose;
6. Another skin cancer within 5cm of the target tumour;
7. Former treatment of BCC in the target area;
8. Allergy for imiquimod 5% cream or substances of the cream.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2007
- planned closingdate1-nov-2009
- Target number of participants80
- Interventions40 patients receive Mohs micrographic surgery with a pretreatment with imiquimod (once daily, 5 days a week, 4 weeks) 40 patients will only undergo Mohs surgery.
- Primary outcomeDefect size after Mohs micrographic surgery.
- Secondary outcome1. Reduction tumour size after using imiquimod 5%cream;
2. Tumour size before Mohs micrographic surgery;
3. Reconstruction time;
4. Cosmetic outcome;
5. Costs;
6. Quality of Life;
7. Recurrence rates;
8. Histologic results, apoptosis.
- TimepointsOctober 2007-March 2008 recruitment of patients;
November 2007-June 2008 treatment of patients;
January 2008-November 2009 Follow-up.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs S Geer van der
- CONTACT for SCIENTIFIC QUERIESDrs S Geer van der
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven,
- PublicationsN/A
- Brief summaryImiquimod is effective for small superficial and nodular BCCs, total or partial clearance is obtained. Imiquimod could decrease tumour size before Mohs micrographic surgery and thereby defect size afterwards, this could improve cosmetic outcome.
- Main changes (audit trail)
- RECORD4-okt-2007 - 20-mrt-2008


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