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.
ID
Bron
Verkorte titel
Aandoening
1. Basal cell carcinoma;
2. Mohs micrographic surgery;
3. imiquimod.
Ondersteuning
No sponsors.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Defect size after Mohs micrographic surgery.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
October 2007-March 2008 recruitment of patients;
November 2007-June 2008 treatment of patients;
January 2008-November 2009 Follow-up.
Onderzoeksproduct en/of interventie
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.
Publiek
Michelangelolaan 2
S Geer van der
Eindhoven 5602 ZA
The Netherlands
simone.vd.geer@cze.nl
Wetenschappelijk
Michelangelolaan 2
S Geer van der
Eindhoven 5602 ZA
The Netherlands
simone.vd.geer@cze.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1048 |
| NTR-old | NTR1081 |
| Ander register | METC Catharina Ziekenhuis Eindhoven : M07-1745 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |