Two-three day treatment provides clinically relevant, sustained
clearance of AK after 12 months
BALLERUP, Denmark, March 20, 2013 /CNW/ - An analysis of long-term
clearance rates of actinic keratosis (AK) lesions after treatment with
ingenol mebutate (Picato®) gel is today published in the Journal of the American Medical Association (JAMA) Dermatology, formerly known as the Archives of Dermatology.
Previously, the pooled results of the four phase III trials of ingenol
mebutate published in the New England Journal of Medicine (NEJM) showed that ingenol mebutate gel effectively clears AK lesions after a
two or three day topical treatment of an area of skin (also known as a
The current data in JAMA Dermatology show that patients who achieved complete clearance after initial
treatment with ingenol mebutate gel, also experience sustained
clearance of AK lesions one year later.
The primary outcome of the study showed that patients showing sustained
complete clearance at 12 months, was 46% on the face and scalp and 44%
on the trunk or extremities. The secondary outcome showed that patients
in the overall population experienced approximately 87% reduction in
the original number of actinic keratoses in the treated area of skin.
The authors of the article 'Long-Term Follow-up of Ingenol Mebutate Gel
for the Treatment of Actinic Keratosis' concluded:
"Ingenol mebutate gel applied as field therapy for only two or three
consecutive daily doses was effective when treating head or body
actinic keratoses, producing clinically relevant sustained clearance
and long-term reduction in lesions."
Author Dr Stephen Shumack, a Consultant Dermatologist from Sydney's
Royal North Shore Hospital, Australia, commented:
"These long-term data are encouraging for patients with actinic
keratosis. It has now been demonstrated that once daily, two or three
day treatment with ingenol mebutate gel leads to a reduction in the
number of actinic keratoses present after 12 months, compared to the
number seen at baseline. These results are comparable to those seen
with other topical therapies with longer treatment durations.These data show long-term effectiveness combined with short duration of
treatment, offering a significant benefit to patients living with
Dr Kim Kjøller, Senior Vice President of Global Development at LEO,
"These data provide clear evidence that ingenol mebutate gel is effective
in sustaining long-term clearance of actinic keratoses. The short
duration of treatment required for ingenol mebutate is an important
step in providing convenient and effective solutions to treat this
Actinic keratoses are rough skin lesions caused by cumulative exposure
to the sun, which can potentially lead to non-melanoma skin cancer
(NMSC) if not treated early and effectively. The majority of lesions are caused by long-term sun exposure in
fair-skinned people. The number of patients with actinic keratosis is
rapidly growing, especially in Europe, the US and Australia.
Ingenol mebutate gel is available in two different concentrations. For
treatment of the face and scalp, ingenol mebutate gel is applied at a
concentration of 150 mcg/g over a 25 cm area once daily for three consecutive days. For treatment of the body,
ingenol mebutate gel is applied over a 25 cm area once daily for two consecutive days at a concentration of 500
Ingenol mebutate gel 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; and by the Therapeutic Goods
Administration (TGA) in Australia, the European Commission (EC) in
Europe in November 2012 and by Health Canada in January 2013.
About Picato® gel
Picato® gel 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
Picato® gel has two strengths and two application regimens to follow,
dependent upon the location of the actinic keratoses. Picato® gel is
applied over a 25cm treatment area for two consecutive days when
treating actinic keratoses on the trunk and extremities (500 mcg/g) and
over three consecutive days for the face and scalp (150mcg/g).
Picato® gel has been shown in a large clinical trial programme to
effectively clear actinic keratosis lesions on the face and scalp, as
well as on the trunk and extremities.
The mechanism of action (MoA) for Picato® gel is not fully understood.
In vivo and in vitro data suggest a dual MoA, including direct lesional
cell death and infiltration of immunocompetent cells.,
Non-invasive examination of skin treated with Picato® gel showed an
almost complete resolution of induced skin changes measured at two
months post treatment, and patients treated with Picato® gel showed a
higher treatment satisfaction than placebo-treated patients in clinical
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® gel.
Picato® gel must not be ingested.
Administration of Picato® gel 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® gel 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® gel.
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 in pregnant women.
Risks to humans receiving cutaneous treatment with ingenol mebutate are
considered unlikely as Picato® gel is not absorbed systemically. As a
precautionary measure, it is preferable to avoid the use of Picato® gel
Actinic keratosis is not a condition generally seen within the pediatric
population. The safety and efficacy of Picato® gel for actinic
keratosis in patients less than 18 years of age have not been
Please see full prescribing information available at http://www.leo-pharma.com.
About actinic keratosis (AK)
Actinic keratoses are skin lesions, which are often red, scaly and may
initially be mistaken for a rash or other skin irritation. The majority
of lesions are caused by sun exposure in fair-skinned people.
The number of patients with actinic keratosis is rapidly growing,
especially in Europe, the US and Australia.
Actinic keratoses are more common in males, and individuals with a fair
skin type. Additional risk factors include advanced age and
immunodeficiency. Immunocompromised patients have a 65 to 250 fold
higher risk for actinic keratoses and invasive squamous cell carcinoma,
which is a type of NMSC.
Actinic keratosis is a precursor to non-melanoma skin cancer which is
the second most common type of skin cancer. ,
After receiving a diagnosis of actinic keratosis, the risk of developing
squamous cell carcinoma over a ten year period is approximately ten per
cent for a patient having an average of 7.7 actinic keratosis
lesions,,, and it is impossible to predict which lesions
will develop into skin cancer.
A study has shown that around between 40-80 per cent of squamous cell
carcinoma cases may begin as actinic keratoses,,, and
patients with the condition are six times more likely to develop any
type of skin cancer than people without it.
About LEO Pharma
Founded in 1908, LEO Pharma is an independent, research-based
LEO Pharma develops, manufactures and markets pharmaceutical drugs to
dermatologic and thrombotic patients in more than 100 countries
The company has its own sales forces in 61 countries and employs around
5,000 people worldwide.
LEO Pharma is headquartered in Denmark and is wholly owned by the LEO
For more information about LEO Pharma, visit http://www.leo-pharma.com.
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SOURCE: LEO Pharma A/S
For further information:
Global Contact: Polly Lutter, Global External Relations Manager, LEO Pharma A/S, Email: email@example.com, +44 (0) 20 7300 6370