Effect of topical imiquimod on lentigo maligna

• Research type

  Research Study

• Full title

  Effect of topical imiquimod on lentigo maligna.

• IRAS ID

  23392

• Contact name

  Jerry Marsden

• Sponsor organisation

  University Hospitals Birmingham NHS Foundation Trust

• Eudract number

  2009-016909-42

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Lentigo maligna (LM) is an early form of cancer which usually appears on the face and neck. In the past, it tended to occur in the over 50??s, but it is becoming more common in younger people. LM appears as a dark patch of skin which grows slowly over the years. At this stage it is harmless because the cancer is only in the outer layer of the skin. However, there is a small possibility that it could grow deeper and there is then a risk of the cancer spreading. Because of this risk, it is important that LM is treated effectively at an early stage. The current treatment is surgery to remove all of the cancerous cells. Although this treatment cures most cases (90-95% cure rate at 5 years) the procedure is invasive, patients often find it stressful and unpleasant and it can result in scarring. The purpose of this study is to see whether a drug, called imiquimod, is an effective alternative to surgery. Recently, imiquimod has been used by many dermatologists to treat LM and the results appear to be good. However, to be sure of how effective imiquimod really is, it is important that we carry out carefully conducted clinical trials like this one. We will look at whether imiquimod cream can kill all the abnormal cells in a LM. The only way to do this safely is to treat the LM with cream and at a later stage remove the area surgically and examine it closely under the microscope. Imiquimod is a cream developed to work with the patient??s immune system to help it fight disease. This type of drug is known as an immuno-modulator. At first, it was only used to treat certain types of wart virus but we now know that it can be effective against basal cell skin cancer and actinic keratosis (rough areas of skin due to sun damage). The results are sufficiently good that imiquimod now has a licence to be used in these conditions.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/111

• Date of REC Opinion

  24 Dec 2009

• REC opinion

  Favourable Opinion