259
Participants
Start Date
December 31, 2012
Primary Completion Date
October 31, 2019
Study Completion Date
November 10, 2022
Imiquimod cream + surgery
Imiquimod (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks (i.e. a total of 20 applications), followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision at 5mm will be performed within a few days (equivalent to 2-stage surgery).
Placebo + surgery
Placebo (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks, followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision of 5mm of clinically healthy tissue will be performed within a few days (equivalent to 2-stage surgery).
Centre Hospitalier Universitaire de Nantes, Nantes
CHU, Besançon
CHU Hôpital Haut-Lévêque, Bordeaux
CHU Hôpital Saint André, Bordeaux
AP-HP Hôpital Ambroise Paré, Boulogne-Billancourt
CHU, Brest
CHU Michallon, Grenoble
CH, Le Mans
CHRU, Lille
CHU, Limoges
CHU, Lyon
AP-HM, Marseille
CHU, Montpellier
CHU, Nice
CHU, Orléans
AP-HP Hôpital Saint Louis, Paris
CHU Milétrie, Poitiers
CHU, Reims
CHU Pontchaillou, Rennes
CHU, Saint-Etienne
Chu (Iucto), Toulouse
CHU, Tours
MEDA Pharma GmbH & Co. KG
INDUSTRY
Nantes University Hospital
OTHER