LEO 43204 Field treatment of AK on the Face or Chest
Research type
Research Study
Full title
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest including 12-month follow-up
IRAS ID
188049
Contact name
Bente Tholstrup
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2015-002449-71
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Derm 5104, CRN Study ID
Duration of Study in the UK
1 years, 4 months, 9 days
Research summary
Actinic keratosis (AK) is a common skin condition visible as thick, scaly, crusty patches of skin (called lesions or Actinic keratoses). AKs develop on areas that are frequently exposed to the sun. Ingenol Mebutate, marketed as Picato® is a gel product applied to the skin to treat AKs in an area of up to 25cm2. LEO 43204 is a new form of ingenol being developed for treatment of AKs on a larger area, such as the full face, balding scalp or a large area on the chest (250 cm2). This trial will look at LEO 43204 gel 0.018% in the treatment of AKs on the face or an area of 250 cm2 on the chest when applied for 3 consecutive days. AKs will be counted prior to treatment and at various points after treatment as a way of measuring how well the treatment works on reducing or clearing AKs in the treatment area. The emergence of new AKs in a defined area will also be recorded to gain some insight as to whether there is a reduction of newly emerging AKs after the treatment. Information on the safety of LEO 43204 gel will be collected as well as some information from the patients themselves. Patients with between 5 and 20 AKs on the face or within a 250cm2 area on the chest will be considered for this trial. Two thirds of the patients will receive LEO 43204 gel and one third will receive a vehicle (placebo). Patients will be followed for 14 months after receiving the treatment and will visit their research site ten times after the screening visit. The data in this trial will contribute to a phase III programme for this product, which may result in a novel treatment for AK over a large treatment area.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0411
Date of REC Opinion
23 Dec 2015
REC opinion
Further Information Favourable Opinion