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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
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
Conditions
Interventions
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).
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