Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Non-invasive lentigo maligna (LM) is characterized by an in situ proliferation of melanoma cells, limited to the epidermis. It is found most commonly on the head and neck of elderly persons, with a peak incidence in the seventh or eighth decade. If untreated, it may develop into invasive melanoma. The gold standard treatment for LM is surgery using a 5-10 mm margin. However, the lesions can be large, and conventional surgery can be difficult, particularly on the face.

Then, there is a need for a topical non-surgical treatment of LM. Ingenol mebutate (IM)/Picato® is able to induce cell apoptosis and an inflammatory reaction in the epidermis and superficial dermis.

Thus, the investigators hypothesize that the topical use of Picato® could induce the cure or a prolonged remission of non-invasive LM.

Because of the exploratory phase of this study (no case report and no clinical trial at the early phase of designing this study, only one case report at the time of submission of this form) the investigators will conduct an open label study limited to patients who are not eligible to, or who refuse surgical treatment of their LM.

The main objective of this study is to determine the proportion of patients with complete response (CR) obtained 2 months after one or two cycles (for patients who did not respond to the first cycle) of topical treatment by IM 150 µg/g for non-invasive LM of the face (head and neck).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Criteria

Inclusion Criteria:

• Subject of both sexes at least 18 years of age

• Patient with a noninvasive LM of the head (face or scalp) which has been proven by biopsy

• LM with a surface area equal or superior to 1 cm2

• Patient who is not eligible to, or refuse surgical treatment

• LM which has not been treated previously or which has already been treated surgically (one or several time) but which is relapsing or which could not been completely removed

• ECOG (Eastern Cooperative Oncology Group) ≤2

• Patient affiliated to French social security

• Patient able to understand and communicate with the investigator and to comply with the requirements of the study

• Patient must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations

Exclusion Criteria:

Location of the LM:

• on the eyelids or within 1 cm of the eyelids

• within 1 cm of the lips

• within 5 cm of an incompletely healed wound

• elsewhere than on the head

• LM which is not strictly intraepidermal, which has an invasive component on the biopsy performed at screening visit

• LM which has had in the past an invasive component, even if it has been surgically treated

• Melanoma of another histopathologic type than LM

• LM with a surface area to be treated (including the 1cm surrounding normal skin) > 25 cm2

• LM whose borders cannot be easily defined

• Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel

• Patient treated with topical steroids or others immunosuppressives drugs (local or systemic agents) within 30 days of entry into this trial

• Patient with active malignancy (other than LM) or a previous malignancy within the past 3 years; except for patient with resected basal cell carcinoma, resected cutaneous squamous cell carcinoma , resected carcinoma in-situ of the cervix, and resected carcinoma in-situ of the breast

• Past medical history record of infection with human immunodeficiency virus

• Organ transplant recipient

• Immunosuppressed subject

• Women of child-bearing potential, or pregnant or lactating

• History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area (e.g., eczema, unstable psoriasis, xeroderma pigmentosum).

• Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to visit 1

• Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment area.

• Current enrolment or participation in a clinical trial within 30 days of entry into this trial

• Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol