No registrations found.
ID
Source
Brief title
Health condition
1. Basal cell carcinoma;
2. Mohs micrographic surgery;
3. imiquimod.
Sponsors and support
No sponsors.
Intervention
Outcome measures
Primary outcome
Defect size after Mohs micrographic surgery.
Secondary outcome
1. 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.
Background summary
Imiquimod 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.
Study objective
Pretreatment 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.
Study design
October 2007-March 2008 recruitment of patients;
November 2007-June 2008 treatment of patients;
January 2008-November 2009 Follow-up.
Intervention
40 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.
Michelangelolaan 2
S Geer van der
Eindhoven 5602 ZA
The Netherlands
simone.vd.geer@cze.nl
Michelangelolaan 2
S Geer van der
Eindhoven 5602 ZA
The Netherlands
simone.vd.geer@cze.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1048 |
| NTR-old | NTR1081 |
| Other | METC Catharina Ziekenhuis Eindhoven : M07-1745 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |