Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face (NCT02723721) | Clinical Trial Compass
CompletedPhase 2
Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face
France20 participantsStarted 2016-06-15
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the clinical and histological complete response (CR) of non-invasive LM 2 months after the end of a treatment cycle. In case of failure of the first cycle, a second will be realized and the CR will be re-assessed at 4.5 months