Could a gel replace surgery for face melanoma?
NCT ID NCT02723721
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a gel called Picato (ingenol mebutate) on 20 people with a very early form of melanoma on the face, called lentigo maligna. Participants applied the gel once a day for three days. The goal was to see if the gel could make the cancer disappear completely, offering a non-surgical option for those who can't or don't want surgery. The study was small and exploratory, and the drug has since been taken off the market for safety reasons.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ingenol mebutate (Picato) gel
- What this could lead to
- If it works, this could offer a non-surgical topical option for treating early-stage melanoma on the face, avoiding the need for surgery.
- What could go wrong
- This is a very small, early-phase study with only 20 participants, and the drug was later withdrawn from the market due to safety concerns, so results may not lead to a widely available treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Jun 2016
- Finished
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Jan 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AP-HP Hopital Avicenne
Bobigny, 93000, France
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AP-HP Hôpital Ambroise Paré
Boulogne-Billancourt, France
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CHRU de Lille
Lille, France
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CHU de Nantes
Nantes, France
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CHU de Nice
Nice, 06000, France
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CHU de Saint Etienne
Saint-Etienne, France
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Hôpital Pontchaillou
Rennes, France
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Hôpital du Morvan
Brest, France