Picato: rapid treatment for actinic keratosis

Picato (ingenol mebutate) is a topical treatment for non-hyperkeratotic and non-hypertrophic actinic keratosis (AK).

Actinic keratosis often appears as red, scaly skin lesions mainly seen on sun-exposed areas such as the face, scalp and extremities
Actinic keratosis often appears as red, scaly skin lesions mainly seen on sun-exposed areas such as the face, scalp and extremities

PHARMACOLOGY

Ingenol mebutate is thought to act by inducing local lesion cell death and promoting an inflammatory response characterised by infiltration of immunocompetent cells.1

CLINICAL STUDIES

The safety and efficacy of ingenol mebutate were assessed in four double-blind, vehicle-controlled studies involving patients with 4–8 AK lesions. In the first two studies, 547 patients were randomised to receive ingenol mebutate 150 microgram/g or vehicle applied to lesions on the face or scalp for 3 consecutive days. In the second two studies, 458 patients received ingenol mebutate 500 microgram/g or vehicle applied to lesions on the trunk and extremities for 2 consecutive days.1

Efficacy endpoints were complete clearance rate (defined as the proportion of patients with no clinically visible AK lesions in the treatment area) and partial clearance rate (defined as the proportion of patients with ≥75 per cent reduction in the number of baseline AK lesions).1

Results

At day 57, all patients treated with ingenol mebutate had significantly higher complete and partial clearance rates than those treated with vehicle (p<0.001).  Patients receiving ingenol mebutate also had significantly higher scores on the Treatment Satisfaction Questionnaire for Medication indicating a higher level of overall satisfaction than those receiving vehicle (p<0.001).1

At 12 months after complete clearance, the recurrence rate in patients treated with ingenol mebutate was 53.9% in patients with face or scalp lesions (n=108) and 56% in patients with lesions on the trunk or extremities (n=76).1

Safety profile

The most common adverse effects observed with ingenol mebutate were headache, eyelid and periorbital oedema and local skin reactions including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration.1 

References:

  1. Picato Summary of Product Characteristics, November 2012.

View Picato drug record

Further information: Leo

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