The FIELD Study Programme, being run by LEO Pharma, has been designed in partnership with leading clinicians to investigate the potential broader role of ingenol mebutate gel in the management of AK.

FIELD Study 1 evaluated the short and long-term e�cacy and safety of treatment of AK on the face or scalp with cryosurgery followed by ingenol mebutate 0.015% field treatment, compared with cryosurgery followed by vehicle gel.5, 6

51.9% of patients administered cryosurgery followed by the vehicle gel experienced the emergence of new AK lesions compared to 38.9% treated with cryosurgery followed by ingenol mebutate (p=0.002).5

Positive benefit comes from both enhancing the e�ect of cryosurgery with ingenol mebutate on the visible baseline lesions and from a field treatment e�ect of ingenol mebutate on sub-clinical lesions not visible at baseline.5

Ingenol mebutate field therapy after cryosurgery was well tolerated.5

Sequential treatment with ingenol mebutate following cryosurgery significantly enhanced the e�cacy of treatment, with a more pronounced relative benefit at 12 months, versus cryosurgery alone.5

FIELD STUDY 1

FIELD Study Repeat evaluated the e�cacy and tolerability of repeating ingenol mebutate treatment for AK within the treated field over a 12 month period.7, 8

FIELD STUDY REPEAT

Ingenol mebutate

*Patients treated twice with ingenol mebutate or treated once and remained clear at 8w, 26w and 44w., 50% were still clear at 12m (44.0%-56.1%, 95% CI)7

50%Overall complete clearance of all AK lesions after one year*

CRYOSURGERYCRYOSURGERY

VEHICLEGEL

Patients with AK present at 8 weeks Patients with complete clearance of AK at 8 weeks

AT BASELINE

AT WEEK 8 AT WEEK 8

All patients received an initial treatment with ingenol mebutate

61.6% of patients treated with ingenol mebutate achieved complete clearance

Patients received a second treatment, randomized to ingenol mebutate or vehicle gel

8 WEEKSLATER

AT WEEK 26 OR 44Patients with AKspresent received a second treatment, randomized to ingenol mebutate or vehicle gel

46.7% of patients treated with ingenol mebutate achieved complete clearance vs. 18.4% vehicle gel (p=0.001)

8 WEEKSLATER59.5% of patients treated with ingenol mebutate achieved complete clearance vs. 25% vehicle gel (p=0.013)

30.5%achieved complete

clearance at 12 months

18.5% achieved complete

clearanceat 12 months

61.6%

59.5%

46.7%

(p=0.01).5 (p=0.01).5

vs.

Repeat use of ingenol mebutate gel in field treatment of AKs on the face and scalp was well tolerated.8

Actinic keratosis (AK) is a precursor to non-melanoma skin cancer (NMSC) which may develop where skin has been exposed to the sun over time.1

If recognised and treatedearly, AKs can be e�ectively treated to prevent NMSC developing.2

Combined, these studies provide further evidence for the role of field treatment with ingenol mebutate in achieving long-term clearance of AK lesions.

1. Sober A. Cancer. 1995; 75(2 Suppl):645-502. Cohen J. J Clin Aesthet Dermatol. 2010; 3:39-443. Ceilley R and Jorizzo J. JAAD. 2013; 68:S28-384. Berman B et al. Cutis. 2012; 89:294-3015. Berman B et al. JDD. 2014; 13:741-76. Berman B. JDD. 2014; 13(2):154-60.7. Garbe C. Ingenol mebutate gel 0.015% repeat use for multiple actinic keratoses on face and scalp: a 12 month phase 3 clinical study. Presented at the World Congress on Cancers of the Skin, Edinburgh, Scotland. 4 September 20148. LP0041-22 Clinical Study Report EudraCT no. 2011-005018-13 01-Jul-2014 page 1,165.

Sub-clinical(invisible) changes

Lesion-specific treatments suchas cryosurgery are used to treat isolated clinical AK lesions, but their major limitation is they do not addressfield cancerization.3

Field cancerization describes both the visible and sub-clinical (invisible) changes in skin cells caused by long-term UV sun exposure.3

Visible changes

Field-directed therapy is theonly treatment approach that is

capable of clearing multipleclinical and sub-clinical AK lesions,

reducing the risk of developingnew lesions over time.4

Sub-clinical (invisible) changes remain untreated with cryosurgery

UV SUN EXPOSURE