Eur J Hosp Pharm 20:60 doi:10.1136/ejhpharm-2012-000218
  • Drug news

EMA approved new drugs: Photodynamic therapy for actinic keratosis

  1. Mark Nolan
  1. Correspondence to Dr Mark Nolan Pharm D, 246 Winslow Way Apt 201, Bainbridge Island, Washington 98110, USA; friendsofpills{at}

Actinic keratoses are superficial neoplasms that develop from sun-damaged skin and, if not treated, may progress to cutaneous squamous cell carcinoma. They tend to appear on the face, scalp, back of the hands, chest or other sun-exposed areas and often appear as flat, scaly, red or pink areas that may be easier to feel than see. According to Cancer Research UK, almost 100 000 cases of non-melanoma skin cancer are diagnosed in the UK each year. This makes it the most common type of cancer by far. This type of cancer also tends to be under-reported. Treatment typically consists of liquid nitrogen cryotherapy, surgical removal, topical 5-fluorouracil, imiquimod, ingenol mebutate, topical diclofenac, retinoids, dermabrasion, chemical peels and/or photodynamic therapy (PDT). Deciding which treatment to choose depends on the size, location and number of lesions. For most cases the inexpensive remedy of liquid nitrogen is the treatment of choice, while those patients who have multiple lesions may benefit from using an alternative treatment. Using nitrogen or surgery can leave unwanted blemishes, particularly on the face, which may be avoided by using PDT. PDT involves using a photosensitiser such as 5-aminolaevulinic acid, which is also a type of porphyrin. One of the best known porphyrins is heme, the pigment in red blood cells. 5-Aminolaevulinic acid accumulates in cells and is metabolised to protoporphyrin IX. When illuminated with red light, protoporphyrin IX will strongly absorb the light and convert it to energy and heat in the illuminated areas. This energy and heat leads to damage of the cellular components and eventually destroys the target cells.

Of special note:

  • Before use: Scales and crusts are carefully removed. All lesions are gently roughened. Care should be taken to avoid bleeding. All lesions are then wiped with an ethanol or isopropanol-soaked cotton pad to degrease the skin.

  • Usual dose: Using gloves or a spatula, apply a thin film of 1-mm thickness to the entire lesion within approximately 5 mm of the surrounding area)

  • Method of use: To be used only on the skin. Avoid mucus membranes or bleeding areas. A distance of 1 cm is to be maintained. Rinse with water if contact occurs. Allow the area to dry for 10 min before placing a light tight dressing over the treatment site. The dressing will be removed after 3 h and remaining gel is wiped away.

  • After cleaning: The entire treated area is illuminated using a red light source. There is no need to protect healthy untreated skin.

  • Duration of use: The treated lesions should be evaluated 3 months after treatment. A second session may be completed if there are still lesions after evaluation.

  • Storage: Keep in refrigerator (2–8°C).

5-Aminolaevulinic acid (Ameluz)

  • Manufacturer: Biofrontera

  • Drug class: Antineoplastic; sensitisers used in photodynamic/radiation therapy; ATC: L01XD04

  • Indication: Treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1–2)

  • Mechanism of action: Following topical application of 5-aminolaevulinic acid, the product is metabolised to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis lesions. Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy. In the presence of oxygen, reactive oxygen species are formed. The latter cause damage of cellular components and eventually destroy the target cells.

  • Posology: One session of photodynamic therapy should be administered for single or multiple lesions. Lesions should be re-evaluated 3 months after treatment. A second session may be required. After application of the gel to the affected areas, a red light directed to the affected area will be required to activate the medication.

Tips for patients

  • Do not use if allergic to:

    – 5-aminolaevulinic acid

    – photoactive substances (also known as porphyrins)

    – soya oil or peanuts.

  • Do not use if you have a blood condition called porphyria or skin conditions caused or made worse by exposure to light.

  • Avoid sun exposure or other ultraviolet light for 48 h after treatment.

  • Inform your provider if you are using medications that can have adverse reactions due to light exposure such as:

    – St John's wort

    – Griseofulvin

    – Thiazides

    – Glimepiride or glibenclamide

    – Some products used to treat mental disorders, nausea or vomiting (ie, medications with names usually ending in ‘azine’ such as promethazine)

    – Some products used to treat bacterial infections (ie, sulpha or antibiotics with names ending with ‘oxacin’ or ‘cycline’, such as levofloxacin or tetracycline)

Information resources

  • EMA: Ameluz. (accessed 10 Dec 2012).

  • Cancer Research UK: Actinic Keratosis. (accessed 10 Dec 2012).

  • UptoDate: Photodynamic therapy. (accessed 10 Dec 2012).


  • Funding  None.

  • Competing interests  None.

  • Provenance and peer review  Not commissioned; internally peer reviewed.

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