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COMPLETED
NCT01720407
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face. Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses. The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

259

Start Date

2012-12

Completion Date

2022-11-10

Last Updated

2026-09-14

Healthy Volunteers

No

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).

Locations (22)

CHU

Besançon, France

CHU Hôpital Haut-Lévêque

Bordeaux, France

CHU Hôpital Saint André

Bordeaux, France

AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, France

CHU

Brest, France

CHU Michallon

Grenoble, France

CH

Le Mans, France

CHRU

Lille, France

CHU

Limoges, France

CHU

Lyon, France

AP-HM

Marseille, France

CHU

Montpellier, France

Centre Hospitalier Universitaire de Nantes

Nantes, France

CHU

Nice, France

CHU

Orléans, France

AP-HP Hôpital Saint Louis

Paris, France

CHU Milétrie

Poitiers, France

CHU

Reims, France

CHU Pontchaillou

Rennes, France

CHU

Saint-Etienne, France

Chu (Iucto)

Toulouse, France

CHU

Tours, France