Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face (PICAMEL)
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|ClinicalTrials.gov Identifier: NCT02723721|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : August 23, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Lentigo Maligna||Drug: Picato gel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face - Study PICAMEL|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: Picato gel
application on1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.
Drug: Picato gel
apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.
- 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 [ Time Frame: at 2 months after end of treatment ]
- disease-free survival [ Time Frame: maximum of 36 months ]calculated from the date of the CR and the date of relapse or death related to the non-invasive LM (very unlikely here). Relapse is defined as the clinical appearance of a new pigmented lesion with histopathological analysis, from one or more biopsy (s), which confirms the diagnosis of non-invasive LM.
- side effects [ Time Frame: at 36 months ]• The type, frequency, severity and the time to onset of side effects will be reported. The side effects will be classified into grades according to WHO criteria and also using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The intensity of short-term local side effects will be evaluated by the Local Skin Reaction score
- specific diagnostic signs of treatment failure [ Time Frame: maximun of 36 months ]
- relapse of non-invasive LM [ Time Frame: maximum of 36 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723721
|Contact: Henri MONTAUDIE, PHemail@example.com|
|Contact: Vanina OLIVERI, CRAfirstname.lastname@example.org|
|AP-HP Hopital Avicenne||Not yet recruiting|
|Bobigny, France, 93000|
|Contact: Liliane LAROCHE, PU-PH|
|AP-HP Hôpital Ambroise Paré||Not yet recruiting|
|boulogne Billancourt, France|
|Contact: Philippe SAIAG, PH|
|Hôpital du Morvan||Not yet recruiting|
|Contact: Laurent MISERY, PU-PH|
|CHRU de Lille||Recruiting|
|Contact: Laurent MORTIER, PU-PH|
|CHU de Nantes||Not yet recruiting|
|Contact: Brigitte DRENO, PU-PH|
|CHU de Nice||Recruiting|
|Nice, France, 06000|
|Principal Investigator: Henri MONTAUDIE, PH|
|Hôpital Pontchaillou||Not yet recruiting|
|Contact: Alain DUPUY, PU-PH|
|CHU de Saint Etienne||Recruiting|
|Saint Etienne, France|
|Contact: Frederic CAMBAZARD, PU-PH|
|Principal Investigator:||Henri MONTAUDIE, PH||Centre Hospitalier Universitaire de Nice|