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Can a skin cream shrink facial melanoma before surgery?

NCT ID NCT01720407

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Lentigo maligna is an early form of melanoma that appears on sun-exposed skin, often on the face. Doctors usually remove it with surgery, but it can be hard to decide how much tissue to take. This trial tests whether applying imiquimod cream for four weeks before surgery can shrink the lesion enough to allow a smaller excision and reduce the chance that surgeons need to go back for more tissue. Participants receive either imiquimod or a placebo cream, then have surgery four weeks later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
imiquimod cream applied to the skin before surgery
What this could lead to
If it works, people with lentigo maligna on the face could need smaller operations and fewer repeat surgeries, with less scarring and better quality of life.
What could go wrong
The cream may not shrink the lesion enough to change the surgery, and it can cause skin irritation. This is a Phase 3 trial, so the approach is still being tested and may not work for everyone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

259 people

The number who actually took part.

Started

Dec 2012

Finished

Nov 2022

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients from both sexes aged over 18 years and operable * Presenting with LM of the face, the neck, or the scalp (in case of hairless scalp only) histologically confirmed by biopsy * Patients presenting with a primitive lesion, of a surface ≥ to 1cm² and ≤ to 20cm², with the possibility of graft or flap reconstruction * LM previously untreated by surgery * LM without prior treatment with liquid nitrogen or any other local treatment within 3 months * ECOG ≤ 2 * Leucocytes ≥ 3,000/mm³ * Neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Haemoglobin ≥ 9.0g/dL * Absence of severe evolutive infection * Absence of known HIV infection * Absence of corticotherapy and treatment by immunosuppressive agents * Absence of excoriation and scarring biopsy prior to application of study treatment * Membership to a social security insurance scheme. * Negative pregnancy test conducted during the inclusion consultation for non-menopausal women. * Effective contraception for patients of childbearing age * Signed informed consent Exclusion Criteria: * LM located on the eyelids are excluded, together with LM in anatomic sites other than the face, the neck or the scalp * Melanomas other than LM * Invasive LM * LM with a surface area \< to 1cm² or \> to 20cm² * LM of which the macroscopic contours cannot be defined * Patients who are allergic to imiquimod excipient (eg hydroxybenzoate) * Patients with a hypersensitivity to active substances or to any of the excipients of the placebo (for example propyl parahydroxybenzoate) * Patients treated by immunosuppressive agents, immunomodulators, cytotoxic agents or corticosteroids (local and systemic) during the 4-week period prior to the selection visit * Patients with auto-immune disease (except vitiligo) or transplant patients * Cutaneous reconstruction not possible * Presence of associated evolutive neoplasia since less than 5 years (with the exception of basal cell carcinoma, Bowen's carcinoma and carcinoma in situ of the cervix) * Patient refusing surgery under local or general anaesthesia * Pregnant women

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Conditions

The condition(s) this trial relates to.

lentigo maligna melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lentigo maligna melanoma (head or neck)

Contacts and locations

Locations

  • AP-HM

    Marseille, France

  • AP-HP Hôpital Ambroise Paré

    Boulogne-Billancourt, France

  • AP-HP Hôpital Saint Louis

    Paris, France

  • CH

    Le Mans, France

  • CHRU

    Lille, France

  • CHU

    Besançon, France

  • CHU

    Brest, France

  • CHU

    Limoges, France

  • CHU

    Lyon, France

  • CHU

    Montpellier, France

  • CHU

    Nice, France

  • CHU

    Orléans, France

  • CHU

    Reims, France

  • CHU

    Saint-Etienne, France

  • CHU

    Tours, France

  • CHU Hôpital Haut-Lévêque

    Bordeaux, France

  • CHU Hôpital Saint André

    Bordeaux, France

  • CHU Michallon

    Grenoble, France

  • CHU Milétrie

    Poitiers, France

  • CHU Pontchaillou

    Rennes, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000, France

  • Chu (Iucto)

    Toulouse, France