Lentigo Maligna Melanoma (Head or Neck)Phase 3ImiReducNCT01720407

Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

A Phase 3 study testing Imiquimod cream + surgery in people with Lentigo Maligna Melanoma (Head or Neck), run by Nantes University Hospital at 22 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lentigo Maligna Melanoma (Head or Neck)
What is being tested?: Imiquimod cream + surgery
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 259 participants
Where: 22 sitesFrance
Study dates: Dec 2012to 10 Nov 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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)

Show all 13Show fewer

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

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

France22 sites

CHU
Besançon
CHU Hôpital Haut-Lévêque
Bordeaux
CHU Hôpital Saint André
Bordeaux
AP-HP Hôpital Ambroise Paré
Boulogne-Billancourt
CHU
Brest
CHU Michallon
Grenoble
CH
Le Mans
CHRU
Lille
CHU
Limoges
CHU
Lyon
AP-HM
Marseille
CHU
Montpellier
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
CHU
Nice
CHU
Orléans
AP-HP Hôpital Saint Louis
Paris
CHU Milétrie
Poitiers
CHU
Reims
CHU Pontchaillou
Rennes
CHU
Saint-Etienne
Chu (Iucto)
Toulouse
CHU
Tours

Other trials in France

About this study

Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.

Read the detailed description

The primary endpoint of the study is to demonstrate that neoadjuvant treatment of LM by imiquimod prior to surgery can reduce the frequency of intralesional excisions as from the first surgical procedure, with a healthy tissue margin of 5mm. Furthermore, the improvement in patient quality of life could also be significant.

The number of patients to be included in the study is 268.

For each patient, the study will involve several stages (S), as follows:

S0 (Selection): information and obtaining of the patient's informed consent. Performance of biopsy for histological confirmation of LM

S1 (S0 + ~ 2 weeks): patient inclusion following anatomopathological confirmation of LM. Patient randomisation in one or other study arm: imiquimod versus placebo and initiation of topical treatment.

S2 (S1 + 4 weeks): Discontinuation of imiquimod/placebo application. Scheduling of the surgical procedure 4 weeks later.

S3 (S2 + 4 weeks): Surgery.

S4: After the last surgical procedure, simple clinical follow up will be ensured every 6 months for a period of 3 years, in order to study the recurrence rate.

Conditions: Lentigo Maligna Melanoma (Head or Neck)
Being tested: Imiquimod cream + surgery, Placebo + surgery
Keywords: Dermatology/ Skin cancers/Lentigo maligna melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Imiquimod cream + surgeryDrug
Imiquimod (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks (i.e. a total of 20 applications), followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision at 5mm will be performed within a few days (equivalent to 2-stage surgery).
Placebo + surgeryDrug
Placebo (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks, followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision of 5mm of clinically healthy tissue will be performed within a few days (equivalent to 2-stage surgery).

Study groups in NCT01720407
Study group	Role	What they receive
Imiquimod	Experimental	Not described Receives: Drug: Imiquimod cream + surgery
Placebo	Placebo comparator	Not described Receives: Drug: Placebo + surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm.
Measured: 10 weeks

Secondary outcomes (3)

The number of surgical re-excisions required to obtain complete remission.
Measured: Baseline, 2 months till 3 years
The number of recurrences, defined as the reappearance of pigmentation within 3 years of surgical excision.
Measured: Baseline, 2 months till 3 years
The number of histologically confirmed complete remissions under imiquimod.
Measured: Baseline, 2 months till 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201210 Nov 2022

First posted2 Nov 2012 (estimated)
Study startDec 2012
Primary completionOct 2019
Study completion10 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lentigo Maligna Melanoma (Head or Neck)Studies of the same condition, open and under way.
More trials run by Nantes University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 259 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01720407
Sponsor's protocol ID: BRD/11/06-S
Acronym: ImiReduc
Status last verified: Dec 2022
First submitted: 23 Oct 2012
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No

Publications

Daude M, Dinulescu M, Nguyen JM, Maillard H, Le Duff F, Machet L, Beylot-Barry M, Legoupil D, Wierzbicka-Hainaut E, Bedane C, Leccia MT, Debarbieux S, Meyer N, Monestier S, Bens G, Denis MG, Bossard C, Vergier B, Khammari A, Dreno B. Efficacy of imiquimod in the management of lentigo maligna. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1785-1791. doi: 10.1111/jdv.19141. Epub 2023 May 6.
PubMed 37114291
Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.
PubMed 36648215

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
ClinicalTrials.gov ID: NCT01720407
Acronym / sponsor ID: ImiReduc / BRD/11/06-S
Conditions: Lentigo Maligna Melanoma (Head or Neck)
Keywords: Dermatology/ Skin cancers/Lentigo maligna melanoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 259 participants (actual)
Lead sponsor: Nantes University HospitalUniversity, hospital or other
Collaborators: MEDA Pharma GmbH & Co. KG
Study start: Dec 2012 (actual)
Primary completion: Oct 2019 (actual)
Study completion: 10 Nov 2022 (actual)
First posted: 2 Nov 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

Detailed description

The number of patients to be included in the study is 268.

For each patient, the study will involve several stages (S), as follows:

S0 (Selection): information and obtaining of the patient's informed consent. Performance of biopsy for histological confirmation of LM

S1 (S0 + ~ 2 weeks): patient inclusion following anatomopathological confirmation of LM. Patient randomisation in one or other study arm: imiquimod versus placebo and initiation of topical treatment.

S2 (S1 + 4 weeks): Discontinuation of imiquimod/placebo application. Scheduling of the surgical procedure 4 weeks later.

S3 (S2 + 4 weeks): Surgery.

S4: After the last surgical procedure, simple clinical follow up will be ensured every 6 months for a period of 3 years, in order to study the recurrence rate.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Imiquimod	Experimental	Drug: Imiquimod cream + surgery
Placebo	Placebo comparator	Drug: Placebo + surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Imiquimod cream + surgeryImiquimod (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks (i.e. a total of 20 applications), followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision at 5mm will be performed within a few days (equivalent to 2-stage surgery).	Drug	Imiquimod
Placebo + surgeryPlacebo (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks, followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision of 5mm of clinically healthy tissue will be performed within a few days (equivalent to 2-stage surgery).	Drug	Placebo

Primary outcome

The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm.
Time frame: 10 weeks

3 secondary outcomes

The number of surgical re-excisions required to obtain complete remission.
Time frame: Baseline, 2 months till 3 years
The number of recurrences, defined as the reappearance of pigmentation within 3 years of surgical excision.
Time frame: Baseline, 2 months till 3 years
The number of histologically confirmed complete remissions under imiquimod.
Time frame: Baseline, 2 months till 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Results publication: PubMed 37114291Daude M, Dinulescu M, Nguyen JM, Maillard H, Le Duff F, Machet L, Beylot-Barry M, Legoupil D, Wierzbicka-Hainaut E, Bedane C, Leccia MT, Debarbieux S, Meyer N, Monestier S, Bens G, Denis MG, Bossard C, Vergier B, Khammari A, Dreno B. Efficacy of imiquimod in the management of lentigo maligna. J Eur Acad Dermatol Venereol. 2023 Sep;37(9):1785-1791. doi: 10.1111/jdv.19141. Epub 2023 May 6.
Derived from this study: PubMed 36648215Gorry C, McCullagh L, O'Donnell H, Barrett S, Schmitz S, Barry M, Curtin K, Beausang E, Barry R, Coyne I. Neoadjuvant treatment for stage III and IV cutaneous melanoma. Cochrane Database Syst Rev. 2023 Jan 17;1(1):CD012974. doi: 10.1002/14651858.CD012974.pub2.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brigitte Dréno, MD, PhD principal investigator

Nantes University Hospital

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imiquimod cream + surgery in people with Lentigo Maligna Melanoma (Head or Neck), run by Nantes University Hospital at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01720407, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.