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

NCT02723721 | Completed Phase 2

• 1 other identifier: 15-PP-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Lentigo Maligna

Keywords

Lentigo maligna

Outcome Measures

Primary Outcomes (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

  at 2 months after end of treatment

Secondary Outcomes (4)

• disease-free survival

  maximum of 36 months

• side effects

  at 36 months

• specific diagnostic signs of treatment failure

  maximun of 36 months

• relapse of non-invasive LM

  maximum of 36 months

Study Arms (1)

Picato gel

EXPERIMENTAL

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

Interventions

Picato gel DRUG

apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.

Picato gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (8)

AP-HP Hopital Avicenne

Bobigny, 93000, France

Location

AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, France

Location

Hôpital du Morvan

Brest, France

Location

CHRU de Lille

Lille, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nice

Nice, 06000, France

Location

Hôpital Pontchaillou

Rennes, France

Location

CHU de Saint Etienne

Saint-Etienne, France

Location

Related Publications (1)

• Montaudie H, Le Duff F, Butori C, Hofman V, Fontas E, Roger-Cruzel C, Bahadoran P, Perrot JL, Desmedt E, Legoupil D, Passeron T, Lacour JP. Ingenol mebutate to treat lentigo maligna of the head (face and scalp): A prospective, multicenter, single-arm phase 2 trial indicates no benefit. J Am Acad Dermatol. 2020 Mar;82(3):731-733. doi: 10.1016/j.jaad.2019.07.035. Epub 2019 Jul 17. No abstract available.

  PMID: 31325551 BACKGROUND

MeSH Terms

Conditions

Hutchinson's Melanotic Freckle

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Henri MONTAUDIE, PH

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 30, 2016
• Study Start: June 15, 2016
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)