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.
The primary endpoint of the study is to demonstrate that neoadjuvant treatment of LM by imiquimod prior to surgery can reduce the frequency of intralesional excisions as from the first surgical procedure, with a healthy tissue margin of 5mm. Furthermore, the improvement in patient quality of life could also be significant. The number of patients to be included in the study is 268. For each patient, the study will involve several stages (S), as follows: S0 (Selection): information and obtaining of the patient's informed consent. Performance of biopsy for histological confirmation of LM S1 (S0 + \~ 2 weeks): patient inclusion following anatomopathological confirmation of LM. Patient randomisation in one or other study arm: imiquimod versus placebo and initiation of topical treatment. S2 (S1 + 4 weeks): Discontinuation of imiquimod/placebo application. Scheduling of the surgical procedure 4 weeks later. S3 (S2 + 4 weeks): Surgery. S4: After the last surgical procedure, simple clinical follow up will be ensured every 6 months for a period of 3 years, in order to study the recurrence rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
259
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 (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).
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
...and 12 more locations
The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm.
Time frame: 10 weeks
The number of surgical re-excisions required to obtain complete remission.
Time frame: Baseline, 2 months till 3 years
The number of recurrences, defined as the reappearance of pigmentation within 3 years of surgical excision.
Time frame: Baseline, 2 months till 3 years
The number of histologically confirmed complete remissions under imiquimod.
Time frame: Baseline, 2 months till 3 years
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