Global study highlights physician preference for topical treatments for actinic keratosis with short treatment duration to improve patient outcomes – presented at EADV

Ballerup, Denmark, 4 October 2013 - Over 90 per cent of physicians treating actinic keratosis (AK) prefer short duration treatment options with fast resolving local skin responses (LSRs),1 is the finding of a global study (‘Physician Perceptions and Experience of Current Treatment in Actinic Keratosis’) that is being presented today at the 22nd Congress of the European Academy of Dermatology and Venereology (EADV).

This is the first study of its kind to look at physician treatment perceptions in actinic keratosis. Over 70 per cent of physicians have concerns about adherence and persistence of topical therapies being negatively influenced by long treatment durations, with local skin responses that may be severe and long lasting.1

Professor Eggert Stockfleth from the Universitätsmedizin in Berlin, Germany, commented on the study as part of the review panel:  

"Actinic keratosis is a chronic condition which can be considered a form of early-stage skin cancer. Therefore it is important that physicians identify treatment options that will lead to improved adherence and ultimately improved outcomes for their patients to ensure satisfaction for patients over the longer term. These findings from over 400 physicians across eight countries provide us with a great insight into AK management and enable us to develop recommendations for improved practice."

“Topical therapy is best form of field therapy”1

The ‘Physician Perceptions and Experience of Current Treatment in Actinic Keratosis’ study also highlighted physicians’ majority view (80 per cent) that field therapy is important for treating AK, with three quarters (76 per cent) of physicians reporting topical therapy as the best form of field therapy.1

AKs are rough skin lesions caused by cumulative exposure to the sun,2 which can lead to non-melanoma skin cancer (NMSC) if not treated early and effectively.3 The number of patients with AK is rapidly growing, especially in Europe, the US and Australia.4  

Some treatments such as cryotherapy target single visible lesions (lesion-directed), whilst others, target an area or field, where visible and non-visible lesions are located (field-directed). Field-directed treatments, such as ingenol mebutate gel, will not only clear obvious AK lesions but also subclinical lesions, reducing the risk of developing new lesions.5

Physician consensus

A global dermatology panel reviewed the findings of the ‘Physician Perceptions and Experience of Current Treatment in Actinic Keratosis’ survey and developed a series of consensus recommendations for AK treatment. At the top of the list was the need for greater physician awareness of the link between AK and SCC.6

Detect and diagnose early

Supporting this recommendation new findings from a Swedish research study (‘Association between AK and SCCIS/SCC – results from a Swedish register-based study’) of 952 people show that many people are not seeking treatment during the early stages of SCC, which suggests that some cases of SCC may have been prevented if AK was detected and diagnosed at an earlier disease stage.7

Cost savings

There are also cost savings associated with the earlier treatment of AK. A second study (‘Treatment patterns and cost of actinic keratosis (AK) during 12 months – a Swedish register-based study’) conducted in the same area of Sweden reviewed the costs associated with treating AK, and concluded that although there are costs associated with the management of AK, the burden for patients, healthcare, and society may be even higher if the disease progresses to SCC.8

Quality of life improvement

AK therapy is associated with local skin responses that are potentially unsightly and associated with pain, discomfort and disruption of daily activities, underlining the importance of assessing treatment satisfaction and quality of life.  Also presented at the congress of EADV were the results of a Quality of Life (QoL) study (‘Effect of ingenol mebutate gel on treatment satisfaction and quality of life in actinic keratosis’), amongst 1,005 patients receiving topical treatment for AK.  The results showed that for those patients treated with ingenol mebutate gel, a novel topical field-directed treatment for AK with a two or three day treatment regimen, a significant improvement in QoL versus placebo was demonstrated, as measured by the TSQM and Skindex-16 surveys. Patients reported that ingenol mebutate gel has a QoL benefit as well as a clinical benefit.9

Professor Matthias Augustin, Universitätsklinikum Hamburg-Eppendorf, Germany who was involved in the data analysis, commented: “This study suggests that patients are satisfied with the short treatment duration and the effect associated with using ingenol mebutate gel. Even patients that were not completely cleared stated improved quality of life when using this treatment.”

A total of nine abstracts were presented featuring data from ongoing LEO Pharma studies and collaborations at the 22nd Congress of EADV in Istanbul. LEO Pharma is committed to helping people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.


Notes to editors

About Picato® (ingenol mebutate gel)
Picato® is a topical, field-directed therapy which is self-administered by the patient to the affected areas of the skin once a day for two or three consecutive days, depending on the treatment location.10

Picato® has demonstrated efficacy in clearing actinic keratosis lesions on the face and scalp, as well as on the trunk and extremities, in a large clinical trial programme.10

Picato® was approved by the US Food and Drug Administration (FDA) in January 2012; by the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil in July 2012; by the Therapeutic Goods Administration (TGA) in Australia and the European Commission (EC) in Europe in November 2012, by Health Canada in January 2013 and by the Swiss Agency of Therapeutic Products (Swissmedic) in June 2013.

Important product information
Contact with the eyes should be avoided. Eye disorders such as eye pain, eyelid oedema and periorbital oedema should be expected to occur after accidental eye exposure of Picato®. Picato® must not be ingested. Administration of Picato® is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised. Picato® should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips.

Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato®. Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised. Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment. There are no data from the use of ingenol mebutate gel in pregnant women. Risks to humans receiving cutaneous treatment with ingenol mebutate gel are considered unlikely as Picato® is not absorbed systemically. As a precautionary measure, it is preferable to avoid the use of Picato® during pregnancy.

Actinic keratosis is not a condition generally seen within the pediatric population. The safety and efficacy of Picato® for actinic keratosis in patients less than 18 years of age have not been established. Please see full prescribing information available at

About actinic keratosis (AK)
Actinic keratoses are common skin lesions which are often red and scaly.2 The majority of lesions are caused by cumulative sun exposure in fair-skinned people.11 Actinic keratosis is a precursor to non-melanoma skin cancer.12 The number of patients with actinic keratosis is rapidly growing, especially in Europe, the US and Australia.4

1. Stockfleth E et al. Physician Perceptions and Experience of Current Treatment in Actinic Keratosis, 2013. e-Poster presented at EADV, Istanbul, 2013 (ID: IST13-0296)
2. Goldberg L and Mamelak A. Journal of drugs in Dermatology. 2010; 9:1125-32
3. Cohen JL. J Clin Aesthet Dermatol. 2010; 3:39-44
4. Ulrich M et al. Expert Opinion. 2010; 15:545 - 55
5. Vatve M et al. Br J Dermatol. 2007; 157:1-4
6. Stockfleth E et al. A Consensus Approach to Improving Patient Adherence and Persistence with Topical Treatment for Actinic Keratosis, 2013. e-Poster presented at EADV, Istanbul, 2013 (ID: IST13-1460)
7. Norlin JM et al. The association between AK and SCCIS/SCC – results from a Swedish register-based study 2013. e-Poster presented at EADV, Istanbul, 2013 (ID: P833; IST13-1020)
8. Norlin JM et al. Treatment patterns and cost of actinic keratosis (AK) during 12 months - a Swedish register-based study, 2013. e-Poster presented at EADV, Istanbul, 2013 (ID: 818; IST13-1027)
9. Augustin M et al. Effect of ingenol mebutate gel on treatment satisfaction and quality of life in actinic keratosis. e-Poster presented at EADV, Istanbul, 2013 (ID: IST13-1530)
10. Lebwohl M et al. N Eng J Med. 2012; 366:1010-9
11. Feldman SR and Fleischer AB, Jr. Cutis. 2011; 87:201-7
12. Sober A. Cancer. 1995; 75(2 Suppl):645-50


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