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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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 vehicle 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.


Detailed Summary:

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.


Sponsor: Nantes University Hospital

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: October 23, 2012
Date Started: December 2012
Date Completion: August 2021
Last Updated: June 6, 2016
Last Verified: June 2016