Ingenol Mebutate Gel, 0.015% Repeat Use for AKs on Face and Scalp

• Research type

  Research Study

• Full title

  Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

• IRAS ID

  91145

• Contact name

  John Lear

• Eudract number

  2011-005018-13

• ISRCTN Number

  n/a

• Research summary

  Actinic keratosis (AK) is a common skin condition visible as thick, scaly, crusty patches of skin (called lesions or Actinic keratoses). Actinic Keratoses (AKs) usually develop on areas that are frequently exposed to the sun. If left untreated, an AK may progress to a squamous cell carcinoma ?? a common form of cancer. There are various treatments for AKs available, some of which treat a specific lesion (e.g.. freezing of the lesion), while others treat a specific area affected by a number of AKs (such as a cream or gel). After both types of treatment, AKs are known to recur and in such cases, patients are usually given a repeat treatment course or alternative treatment. The drug to be tested in this study is ingenol mebutate gel 0.015%, which will be applied to an area of 25cm2. Ingenol mebutate gel 0.015% has previously been tested as a single use treatment, but this study would test a repeat treatment ?? a practice consistent with common management of patients with AKs. Eligible patients would be seeing a dermatologist for the treatment of their AKs, and would have 4-8 AKs within a 25 cm2 area of their face or scalp. All patients are initially treated for 3 consecutive days with a once daily application of ingenol mebutate gel 0.015%, applied to a 25 cm2 affected area of their face or scalp. After 8 weeks, patients who are completely cleared of all AKs in their treated area, will continue and enter an observation period. Those who are not completely cleared after 8 weeks, and those who develop AKs during the observation period, will receive a second 3-day cycle of ingenol mebutate gel 0.015%, or vehicle (the same gel but without the active ingredient ingenol mebutate).

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0177

• Date of REC Opinion

  24 Apr 2012

• REC opinion

  Further Information Favourable Opinion