Risk of SCC on skin treated with Ingenol Mebutate or Imiquimod Cream
Research type
Research Study
Full title
Risk of Squamous Cell Carcinoma on Skin Areas Treated with Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
IRAS ID
124757
Contact name
Girish Gupta
Contact email
Sponsor organisation
LEO Laboratories Ltd
Eudract number
2012-003112-31
Research summary
Actinic keratosis (AK) is a common skin condition visible as thick, scaly, crusty patches of skin called solar keratoses, actinic keratoses, or an AK lesion. Actinic keratoses (AKs) usually develop on areas of skin that are frequently exposed to the sun. If left untreated, an AK lesion may progress to a squamous cell carcinoma (SCC) – a common form of cancer. Patients that present with numerous AKs are often treated with a topical treatment (a cream/ointment/gel that is applied to the skin). This study will involve a topical product called ingenol mebutate 0.015% gel (marketed as Picato® in the UK) and the comparator drug imiquimod 5% cream (Aldara). Although there is evidence to suggest AKs progress onto SCC, this study will explore whether there is an additional risk of developing SCC following treatment with ingenol mebutate gel or imiquimod cream. The study will also compare how well both products work for the treatment of AK. In order to be eligible for the study, subjects would be seeing a dermatologist for the treatment of their AKs, would have 5-9 AKs within a selected treatment area of 25cm2, and must have a biopsy to confirm the diagnosis of AK. Patients who are enrolled into the study will be treated with ingenol mebutate 0.015% gel once daily for 3 consecutive days, or imiquimod 5% cream, once daily application, 3 days a week for 4 weeks. Both subjects and investigators will know what treatment the patient is receiving. After 8 weeks if any AKs remain within the treated area, the treatment will be repeated with the same drug. All patients will be followed up until 3 years after randomisation in order to monitor for any occurrence of SCC, which if suspected within this time period, must be confirmed by performing another biopsy.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0463
Date of REC Opinion
13 Jul 2013
REC opinion
Favourable Opinion