Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

PHASE3CompletedINTERVENTIONAL
Enrollment

259

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

October 31, 2019

Study Completion Date

November 10, 2022

Conditions
Lentigo Maligna Melanoma (Head or Neck)
Interventions
DRUG

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).

DRUG

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).

Trial Locations (22)

44000

Centre Hospitalier Universitaire de Nantes, Nantes

Unknown

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

All Listed Sponsors
collaborator

MEDA Pharma GmbH & Co. KG

INDUSTRY

lead

Nantes University Hospital

OTHER

NCT01720407 - Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face | Biotech Hunter | Biotech Hunter