Photodynamic therapy with BF‐200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer‐blind phase III study in comparison with a registered methyl‐5‐aminolaevulinate cream and placebo

@article{Dirschka2012PhotodynamicTW,
  title={Photodynamic therapy with BF‐200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer‐blind phase III study in comparison with a registered methyl‐5‐aminolaevulinate cream and placebo},
  author={Thomas Dirschka and Peter Radny and Rolf Dominicus and Hartwig Mensing and Harald Br{\"u}ning and Lars Jenne and L Karl and Michael Sebastian and Claus Oster-Schmidt and Winfried Kl{\"o}vekorn and Uwe Reinhold and Mark Tanner and Dirk Gr{\"o}ne and Martin Deichmann and M Simon and F. H{\"u}binger and G{\"u}nther F.L. Hofbauer and G Kr{\"a}hn-Senftleben and F. Borrosch and Kristian Reich and Carola Berking and Peter Wolf and Percy Lehmann and Marion Michaela Moers-Carpi and Herbert H{\"o}nigsmann and Karin Wernicke-Panten and Christoph Helwig and Montserrat Foguet and Beate Schmitz and Hermann Lübbert and R M Szeimies},
  journal={British Journal of Dermatology},
  year={2012},
  volume={166}
}
Background  Photodynamic therapy (PDT) with 5‐aminolaevulinic acid (ALA) or its methylester [methyl‐5‐aminolaevulinate (MAL) or 5‐amino‐4‐oxopentanoate] was recently ranked as first‐line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF‐200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA… 
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A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis.
TLDR
Clinical data on BF-200 ALA for AK is reviewed along with a summary of molecular mechanisms and future perspectives, and a selective, field-directed treatment is ideal to meet the requirements of field change.
Daylight photodynamic therapy for actinic keratoses: a randomized double‐blinded nonsponsored prospective study comparing 5‐aminolaevulinic acid nanoemulsion (BF‐200) with methyl‐5‐aminolaevulinate
Daylight‐mediated photodynamic therapy (DL‐PDT) using methyl‐5‐aminolaevulinate (MAL) is effective for thin, grade I, actinic keratoses (AK). There are no published studies of other photosensitizers…
A randomized, double‐blind, phase III, multicentre study to evaluate the safety and efficacy of BF‐200 ALA (Ameluz®) vs. placebo in the field‐directed treatment of mild‐to‐moderate actinic keratosis with photodynamic therapy (PDT) when using the BF‐RhodoLED® lamp
TLDR
The efficacy and safety of field treatment of multiple actinic keratosis lesions with PDT with photodynamic therapy has never before been tested in a pivotal trial.
Photodynamic Treatment of Actinic Keratosis Using Ameluz ® : Recapitulation of Clinical Phase III Studies in the Light of Novel Preclinical Research
TLDR
A very recent multinational, multi-centre, prospective, placebocontrolled phase III study comparing an ALA and a MAL preparation demonstrated strongly superior efficacy of Ameluz over Metvix, in both the primary and secondary read-outs total patient and total lesion clearance, but application site pain was not elevated along with the increased efficacy.
Topical Photodynamic Therapy with Different Forms of 5-Aminolevulinic Acid in the Treatment of Actinic Keratosis
TLDR
Positive results suggest that PDT with the use of ALA-P in AK treatment may be an advantageous alternative to the already used ALA -HCl and MAL-HCl.
A randomized, intraindividual, non‐inferiority, Phase III study comparing daylight photodynamic therapy with BF‐200 ALA gel and MAL cream for the treatment of actinic keratosis
TLDR
Major obstacles of PDT are the need of a special illumination device and pain accompanying the illumination, which may be overcome by replacing an artificial high‐power light source with natural daylight for more extended illumination at lower light doses.
Update on photodynamic treatment for actinic keratosis.
TLDR
Three randomised studies have shown that daylight-PDT is an effective and pain-free treatment for AK; however, the procedure is limited by the need for a sufficient light dose and outdoor temperature.
Split‐face study comparing conventional MAL photodynamic therapy in multiple actinic keratosis with complete time vs. half‐time red light LED conventional illumination
TLDR
The difference in the doses of red light applied between these two methods suggests that an intermediate dose with red light conventional illumination could be effective in PDT of actinic keratosis.
Red light photodynamic therapy with BF-200 ALA showed superior efficacy in the treatment of actinic keratosis on the extremities, trunk and neck in a vehicle-controlled Phase III study.
Day light photodynamic therapy with BF‐200 ALA: A case series
TLDR
This study conducted following the Spanish-Portuguese consensus statement on DL-PDT with methyl-5-aminolevulinate (MAL) in the treatment of AKs treated 25 patients with a mean age of 76 years, diagnosed clinically with AK II and III regarding Olsen classification and a field size less than 20 cm with main advantage of BF-200 ALA compared with MAL.
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References

SHOWING 1-10 OF 34 REFERENCES
Photodynamic therapy with BF‐200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double‐blind, placebo‐controlled phase III study
TLDR
Photodynamic therapy with 5‐aminolaevulinic acid (ALA) provides a therapeutic option for the treatment of actinic keratosis and a new stable nanoemulsion‐based ALA formulation, BF‐200 ALA, is in clinical development for PDT of AK.
Topical Methyl Aminolevulinate Photodynamic Therapy Using Red Light‐Emitting Diode Light for Multiple Actinic Keratoses: A Randomized Study
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    Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
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TLDR
Topical MAL PDT using a LED and topical methyl aminolevulinate for treatment of multiple AKs is an effective treatment for multipleAKs.
Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: A prospective, randomized study.
TLDR
Investigation of the complete response rates, cosmetic outcome, and patient satisfaction after photodynamic therapy (PDT) using methyl 5-aminolevulinate versus cryotherapy in the treatment of AK found PDT giving better cosmetic results and higher patient satisfaction than cryotherapy.
Photodynamic therapy using topical methyl 5-aminolevulinate compared with cryotherapy for actinic keratosis: A prospective, randomized study.
Randomized, double‐blind, prospective study to compare topical 5‐aminolaevulinic acid methylester with topical 5‐aminolaevulinic acid photodynamic therapy for extensive scalp actinic keratosis
TLDR
This data indicates that MAL is a more effective treatment option for actinic keratosis than ALA in the treatment of extensive scalp AK, but no studies have directly compared their efficacy.
Optimization of photodynamic therapy with a novel self‐adhesive 5‐aminolaevulinic acid patch: results of two randomized controlled phase III studies
TLDR
A thin self‐adhesive patch containing 5‐aminolaevulinic acid (5‐ALA) was developed to facilitate PDT and showed promising results in treatment of actinic keratoses.
Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized, double-blind, placebo-controlled study.
Guidelines on the use of photodynamic therapy for nonmelanoma skin cancer: an international consensus. International Society for Photodynamic Therapy in Dermatology, 2005.
Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12‐month follow up
TLDR
Treatment and management of actinic keratoses are integral components to quality dermatological health care, especially among individuals with light complexions.
Photodynamic therapy in dermatology – an update
TLDR
The benefits of PDT are the low level of invasiveness and the excellent cosmetic results after treatment, and the applied light dose and the concentration of the photosensitizer either cytotoxic effects resulting in tumor destruction or immunomodulatory effects improving the inflammatory conditions occur.
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