In the context of conventional photodynamic therapy (c-PDT) with red light, Ameluz® (78 mg/g 5-aminolaevulinic acid gel) is approved for the treatment of¹

• Actinic keratosis (AK) and field cancerisation*
• Appropriate forms of basal cell carcinoma (BCC)**

* Actinic keratosis of mild to moderate severity (grade 1 to 2 according to Olsen) and field cancerisation in adults
** Superficial and/or nodular basal cell carcinoma in adults not suitable for surgical treatment due to possible disease-related

Appropriate light sources^1, ***:

• Narrow spectrum of approximately 630 nm and light dose of approximately 37 J/cm2
• Broad spectrum from 570 to 670 nm and light dose from 75 to 200 J/cm2

*** Efficacy of treatment of AK on the trunk, neck, and extremities has been demonstrated only in the setting of narrow-spectrum red light PDT.

Since March 2020, Ameluz® has been approved with c-PDT for the field-directed treatment of AK on the trunk, neck and extremities, the only photosensitising agent with this indication.
Conventional PDT can be performed all year round and is not dependent on weather conditions.
The procedure is carried out entirely under medical supervision in the dermatological practice and thus under controlled and standardised conditions.

Procedure for conventional PDT with Ameluz^®1

For lesions on the face and scalp

• First, the skin areas to be treated are thoroughly degreased with ethanol or isopropanol, scales and crusts are carefully removed and the lesions are carefully roughened.
• The PDT drug Ameluz® with the photosensitiser precursor 5-aminolevulinic acid (5-ALA) is then applied to the prepared skin areas.
• In the next step, a light-tight dressing is applied to the treatment areas.
• This is followed by a three-hour incubation period. During this period, 5-ALA is metabolised to the photosensitiser protoporphyrin IX, which accumulates in the target cells.
• Three hours after incubation, the remaining gel is removed from the entire treatment area, which is then exposed to a red-light source.
• After each PDT session the treated areas and surrounding skin should be protected from sunlight for 48 hours after each PDT session.
• For full details of the treatment steps please see the summary of product characteristics.

For the treatment of single and multiple lesions of basal cell carcinoma (BCC), two sessions of PDT are recommended with an interval of about one week between sessions.
To evaluate the success of the treatment, it is recommended to perform a follow-up examination 3 months after the first treatment. Any remaining lesions should be retreated according to the treatment regimen.¹