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
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Photodynamic therapy with daylight: Low pain & high efficacy1

In the context of photodynamic therapy (PDT) with daylight, Ameluz® (78 mg/g 5-aminolaevulinic acid gel) is approved for the treatment of actinic keratosis (AK) and field cancerisation on the face and scalp.2,*

* Actinic keratosis of mild to moderate severity (grade 1 to 2 according to Olsen) and field cancerisation in adults.

 

Daylight PDT should only be performed when a comfortable two-hour outdoor stay is possible. The following requirements should be met2:

  • The outside temperature must be over 10 °C
  • It should not rain
  • Direct sunlight is not required, normal daylight is sufficient

Advantages of daylight PDT

Daylight PDT – well tolerated with low levels of pain reported
In daylight PDT, protoporphyrin IX (PpIX) synthesis and activation occur simultaneously during the two-hour daylight exposure. This results in less PpIX accumulation than conventional PDT and therefore leads to better tolerability.1,3

High therapy adherence – high efficacy
Topical AK treatments often require prolonged periods of treatment (up to as much as 90 days) which can lead to a reduction in adherence, A lack of adherence can negatively influence the effectiveness of the chosen form of therapy.4,5

In contrast to topical AK treatments, daylight PDT requires only one treatment with a high adherence and efficacy.1,4 On average about 79.8% of all AK lesions (Olsen grade 1 and 2) on the face and scalp completely cleared with a single daylight PDT.1,2

Patient satisfaction with daylight PDT
The convenience of the treatment leads to high levels of patient satisfaction. In a survey respondents ranked minimal pain/discomfort, disease clearance, convenience of outdoor treatment and good cosmetic outcome as important factors for dPDT, with 82% being happy or very happy with the service.6

Procedure for daylight PDT with Ameluz®2

  • Firstly, a sunscreen (at least SPF 30) without physical filters should be applied to the skin areas exposed to the sun.
  • After about 15 minutes, the skin areas to be treated are thoroughly degreased with ethanol or isopropanol, scales and crusts are removed and the lesions are carefully roughened.
  • The PDT drug Ameluz®, which contains the photosensitiser precursor 5-aminolaevulinic acid (5-ALA), is then applied thinly to the prepared skin areas.
  • After no more than 30 minutes of incubation, the patient goes outdoors and stays there, preferably without interruption, for 2 hours in full daylight.2
  • After the end of light exposure, the remaining gel is removed.

In the following 48 hours, the patient should protect the treated areas from sunlight. To evaluate the treatment success, it is recommended to perform a follow-up examination 3 months after the treatment. Any remaining lesions can then be treated again.2

References

  1. Dirschka T et al. J Eur Acad Dermatol Venereol 2019;33:288-297.
  2. Ameluz® Summary of Product Characteristics.
  3. Reinhold U. Future Oncology 2017;13:2413-2428.
  4. Foley et al. J Dermatolog Treat. 2016 Nov:27(6):538-545
  5. Shergill B et al. Patient Prefer Adherence 2013;8:35-41.
  6. McLellan LJ et al. BJ Dermatol 2019;181:828–873

UKBF-2022-006d-V01, Date of preparation: September 2022