Date: 2014-09-04
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 15th World Congress of Cancers of the Skin (WCCS) in Edinburgh
Company: Leo Pharma (Denmark)
Product: Picato® (ingenol mebutate)
Action
mechanism: The active substance of Picato® is ingenol mebutate, an antibiotic and chemotherapeutic for dermatological use (D06BX02) that causes induction of local lesion cell death and promotes an inflammatory response characterised by infiltration of immunocompetent cells.
Disease: actinic keratosis
Therapeutic area: Dermatological diseases
Country:
Trial
details: The FIELD Study Repeat is part of the larger international FIELD Study Programme being run by LEO Pharma, designed in partnership with leading clinicians to investigate the potential broader role of Picato® in the management of actinic keratosis. The FIELD Study Repeat involved 450 patients across 5 countries globally, designed to explore the efficacy and tolerability of Picato® repeated treatment within the same area or ‘field’ on the face or scalp over a 12 month period. (NCT01600014). The FIELD Study 1 involved more than 300 patients across 35 US trial sites and explored the efficacy and safety profile of sequential treatment of AK on the face or scalp with cryosurgery followed by Picato®, 0.015% treatment compared with cryosurgery followed by vehicle gel. (NCT01541553).
Latest
news: * On September 4, 2014, LEO Pharma announced that new data from the international FIELD Study Repeat presented at the 15th World Congress of Cancers of the Skin (WCCS) in Edinburgh, Scotland, demonstrate initial treatment with Picato® (ingenol mebutate gel) 0.015% is efficacious in treating actinic keratoses (AK) and, when followed by a repeat cycle for persistent and newly emerging AKs, this efficacy is further increased. The data also confirm two treatment cycles of Picato® are well tolerated by patients. These findings are significant as AK is a chronic disease.The presence of underlying sub-clinical (invisible) lesions can lead to recurrence of original AKs and the development of new lesions over time, which normally require repeat treatment. The FIELD Study Repeat followed patients over a one-year-period, confirming both the short and in particular the long-term benefits when treating once or twice of Picato® – with an overall 50% complete clearance of all AK lesions after one year. The FIELD Study Repeat is part of the larger international FIELD Study Programme being run by LEO Pharma, designed in partnership with leading clinicians to investigate the potential broader role of Picato® in the management of AK. Additional data from the FIELD Study Programme was recently published in the Journal of Drugs in Dermatology (JDD) with the long-term results of the FIELD Study 1, investigating the efficacy of Picato® as a field-directed therapy used sequentially following treatment with cryosurgery. Results show that combining lesion-specific cryosurgery with Picato® field therapy significantly improves the clearance of AK lesions, with an overall 30.5% complete clearance rate, compared to 18.5% with cryosurgery plus vehicle gel over a one year period. This elevated efficacy results from enhancing the effect of cryosurgery with Picato® on the visible baseline lesions, and from a ‘field treatment effect’ of Picato® on subclinical lesions not visible at baseline (demonstrated by fewer patients experiencing new lesions when treated with Picato® compared to vehicle gel).4 The data also confirm Picato® field therapy after cryosurgery is well tolerated.
