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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BF-RhodoLED®

The BF-RhodoLED® is a narrow-spectrum red light lamp developed by Biofrontera for conventional photodynamic therapy (PDT), whose LEDs emit light with a peak wavelength of approx. 635 nm. This wavelength is ideally suited for PDT with Ameluz® (78 mg/g 5-aminolaevulinic acid gel).
The CE certification of the BF-RhodoLED® took place in November 2012.
The BF-RhodoLED® includes an adjustable patient fan and allows modification of the light intensity whilst delivering a consistent light dose. Both these features have been included to enhance patient comfort where required.1,2

Technical details of the BF-RhodoLED®:

  • Stowage dimension: 95 x 62 x 168 cm (W x L x H)
  • 128 high quality power LEDs with long lifetime
  • Exposure field 8 x 18 cm, effective exposure field 6 x 16 cm
  • Typical peak wavelength: 635 nm
  • Typical radiation intensity: 61 mW/cm²
  • All exposure programs apply a light dose of 37 J/cm²
  • At continuous maximum intensity, recommended light dose is achieved within 10 min
  • Treatment distance: 5-8 cm
  • Homogeneous light distribution
  • No UV radiation
  • Skin ventilator

In the following publications the BF-RhodoLED® was used as light source:

Novak et al., Photodiagnosis Photodyn Ther. 2016 Jun;14:128-30.

Reinhold et al., Br J Dermatol. 2016 Oct;175(4);696-705.

Wollina et al., Georgian Med News. 2018 Jan;(274);138-143.

Schmitz et al., Photodiagnosis Photodyn Ther. 2018 Mar;21:66-70.

Novak et al., Photodiagnosis Photodyn Ther. 2018 Mar;21:385-392.

Morton et al., Br J Dermatol. 2018 Aug;179(2):309-319.

Zaar et al., Photodermatol Photoimmunol Photomed. 2018 Sep;34(5):338-342.

Gholam et al., Photodermatol Photoimmunol Photomed. 2019 Mar;35(2):110-115.

Alique-Garcia et al., Photodiagnosis Photodyn Ther. 2019 Jun;26:190-192.

Wollina et al., Open Access Maced J Med Sci. 2019 Aug 20;7(18):2998-3001.

Alique-Garcia et al., Photodiagnosis Photodyn Ther. 2019 Dec;28:192-194.

Bigge et al., Translational Biophotonics. 2020;2:e201900037

Navarro-Triviño et al., Dermatol Ther. 2021 Jan;34(1):e14558.

Meierhofer et al., Photodermatol Photoimmunol Photomed. 2021 Jan;37(1):56-62.

Ulrich et al., J Am Acad Dermatol. 2021;S0190-9622(21)00575-2

References

  1. Zaar et al. Photodermatol Photoimmunol Photomed 2018;34:338-342.
  2. Gholam et al. Photodermatol Photoimmunol Photomed 2019;35:110-115.

UKBF-2022-006m-V01, Date of preparation: June 2022