Ingenol mebutate (trade name: Picato) gel has been approved in Germany since November 2012 for the treatment of certain types of actinic keratosis. Due to lack of suitable data it has not been possible to compare the drug with the current standard therapy.
Actinic keratosis is a skin disease in which the uppermost layer of skin hardens and gradually forms a callus. It develops from frequent exposure of skin cells called keratinocytes to intense UV radiation, which causes them to mutate and multiply. Skin on the face, arms and legs, neck and back is most vulnerable. The condition may also turn into a type of skin cancer called squamous cell carcinoma.
There are different types of actinic keratosis, which vary depending on the severity of callus formation. Ingenol mebutate has been approved for treating cases of actinic keratosis where the skin has stayed smooth and is not too callused - referred to as non-hyperkeratotic and non-hypertrophic actinic keratosis. Skin affected by these types of keratosis can turn rough and scaly.
Ingenol mebutate is applied to the skin as a gel. The gel is available in two different doses: 150 or 500 micrograms of ingenol mebutate per gram of gel. One tube of either dose is enough to treat a 5 cm by 5 cm patch of skin.
The lower dose is used when treating the scalp or facial skin. The skin is treated for three consecutive days using one tube per day.
The higher dose is used for treating skin on other parts of the body body, like the limbs or back. This dose is applied to the affected areas for two consecutive days, using one tube per day.
Standard treatment for adults with actinic keratosis is diclofenac and hyaluronic acid gel.
In 2013, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) compared ingenol mebutate with treatment using diclofenac and hyaluronic acid gel for actinic keratosis in adults. However, the manufacturer did not provide any suitable data to make a proper comparison.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of ingenol mebutate (Picato).
The next time we check whether this information is still up-to-date will be during the update of the topic non-melanoma skin cancer.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ingenolmebutat – Benefit assessment according to § 35a Social Code Book V. Dossier assessment A13-04. Cologne: IQWiG. April 15, 2013.
IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. We do not offer individual consultations.
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.