Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Biofrontera Pharma GmbH on +49 214 876 32 66 or Ameluz@biofrontera.com
Biofrontera Biofrontera
Welcome to our
website for Healthcare
Professionals
  1. Home

Photodynamic therapy (PDT) with Ameluz® (78 mg/g 5-aminolaevulinic acid gel)

Ameluz® is indicated for:

The treatment of actinic keratoses of mild to moderate severity (grade 1 to 2 according to Olsen) and field cancerization in adults.1

The treatment of superficial and/or nodular basal cell carcinoma that is not suitable for surgical treatment due to possible disease-related morbidity and/or poor cosmetic results.1

Actinic keratoses (AKs) are precancerous lesions of the epidermis. They usually result from chronic exposure to ultraviolet (UV) radiation.2 Therefore, they typically occur on areas of the body that are highly exposed to UV light, such as the face, ears, hairless scalp, neck/décolleté, back of the hands, forearms, and shoulders.3

Actinic keratosis is not uncommon. NICE estimate that over 23% of the UK population aged 60 and above have AK.4

Why is this a concern? AKs are considered an early form of squamous cell carcinoma (SCC). The presence of ten AK lesions is associated with a 14% risk of developing an invasive SCC within five years.4 To prevent the progression of AKs to invasive SCC, all patients with AK should be treated early and effectively.5

At Biofrontera our research and development teams are continually looking at how we can improve the treatment of non-melanoma skin cancer and its precursors.

On this platform, you will find information on the conditions treated, the science behind PDT and Ameluz® as well as details of some of the clinical trials that have been carried out using it.

 

Ameluz® mechanism of action

Ameluz® is indicated for:

The active substance (5-aminolevulinic acid) is applied to the skin as a gel and is selectively taken up by the damaged cells, where it accumulates and is metabolised to the photosensitizer, protoporphyrin IX (PpIX). This is itself activated by certain wavelengths of light, and in the presence of oxygen, will form reactive oxygen species (ROS) that destroy the target cells.6

Ameluz® can be used in both conventional PDT and daylight PDT.1

References

  1. Ameluz® Summary of Product Characteristics.
  2. De Berker et al. Br J Dermatol. 2017 Jan; 176(1): 20–43
  3. Emre S. World J Dermatol 2016;5:115-124.
  4. Primary Care Dermatology Society Guidelines https://www.pcds.org.uk/clinical-guidance/actinic-keratosis-syn-solar-keratosis (Last accessed November 2022)
  5. Werner RN et al. J Eur Acad Dermatol Venereol 2015;29:2069-2079.
  6. Reinhold U. Future Oncol 2017;13:2413-2428.

UKBF-2022-006a-V01, Date of preparation: November 2022