Lentigo Maligna Melanoma (Head or Neck) Clinical Trial
— ImiReducOfficial title:
Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
| Verified date | December 2022 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 259 |
| Est. completion date | November 10, 2022 |
| Est. primary completion date | October 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients from both sexes aged over 18 years and operable - Presenting with LM of the face, the neck, or the scalp (in case of hairless scalp only) histologically confirmed by biopsy - Patients presenting with a primitive lesion, of a surface = to 1cm² and = to 20cm², with the possibility of graft or flap reconstruction - LM previously untreated by surgery - LM without prior treatment with liquid nitrogen or any other local treatment within 3 months - ECOG = 2 - Leucocytes = 3,000/mm³ - Neutrophil count = 1,500/mm³ - Platelet count = 100,000/mm³ - Haemoglobin = 9.0g/dL - Absence of severe evolutive infection - Absence of known HIV infection - Absence of corticotherapy and treatment by immunosuppressive agents - Absence of excoriation and scarring biopsy prior to application of study treatment - Membership to a social security insurance scheme. - Negative pregnancy test conducted during the inclusion consultation for non-menopausal women. - Effective contraception for patients of childbearing age - Signed informed consent Exclusion Criteria: - LM located on the eyelids are excluded, together with LM in anatomic sites other than the face, the neck or the scalp - Melanomas other than LM - Invasive LM - LM with a surface area < to 1cm² or > to 20cm² - LM of which the macroscopic contours cannot be defined - Patients who are allergic to imiquimod excipient (eg hydroxybenzoate) - Patients with a hypersensitivity to active substances or to any of the excipients of the placebo (for example propyl parahydroxybenzoate) - Patients treated by immunosuppressive agents, immunomodulators, cytotoxic agents or corticosteroids (local and systemic) during the 4-week period prior to the selection visit - Patients with auto-immune disease (except vitiligo) or transplant patients - Cutaneous reconstruction not possible - Presence of associated evolutive neoplasia since less than 5 years (with the exception of basal cell carcinoma, Bowen's carcinoma and carcinoma in situ of the cervix) - Patient refusing surgery under local or general anaesthesia - Pregnant women |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital | MEDA Pharma GmbH & Co. KG |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 10 weeks | ||
| Secondary | The number of surgical re-excisions required to obtain complete remission. | Baseline, 2 months till 3 years | ||
| Secondary | The number of recurrences, defined as the reappearance of pigmentation within 3 years of surgical excision. | Baseline, 2 months till 3 years | ||
| Secondary | The number of histologically confirmed complete remissions under imiquimod. | Baseline, 2 months till 3 years |