Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face
Status:
Unknown status
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
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).