Evidence map›Paper›PMID 39666443›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

Long-term follow-up of a randomized, double-blind, phase III, multi-centre study to evaluate the safety and efficacy of field-directed photodynamic therapy (PDT) of mild to moderate actinic keratosis using BF-200 ALA versus placebo and the BF-RhodoLED® lamp.

U Reinhold, W G Philipp-Dormston, T Dirschka, R Ostendorf, R Aschoff, C Berking, A Jäger, B Schmitz, M Foguet, R-M Szeimies

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01966120 (A Randomized, Double-blind, Phase III, Multi-center Study to Evaluate the Safety and Efficacy of BF-200 ALA), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01966120 phase3completednot on this map

A Randomized, Double-blind, Phase III, Multi-center Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) Versus Placebo in the Field-directed Treatment of Mild to Moderate Actinic Keratosis With Photodynamic Therapy (PDT) When Using the BF-RhodoLED® Lamp

TypeinterventionalSponsorBiofrontera Bioscience GmbHRan2013 to 2015Enrolled87ConditionsActinic KeratosisArmsBF-200 ALA gel, Placebo to BF-200 ALA gel, Photodynamic therapy with BF-RhodoLED
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

U ReinholdMVZ Dermatological Center Bonn, Bonn, Germany.ORCID https://orcid.org/0000-0001-8970-8256
W G Philipp-DormstonHautzentrum Köln, Cologne, Germany.ORCID https://orcid.org/0000-0001-9745-2369
T DirschkaFaculty of Health, University Witten/Herdecke, Witten, Germany.
R OstendorfPrivate Practice, Mönchengladbach, Germany.
R AschoffDepartment of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
C BerkingDepartment of Dermatology, CCC Erlangen-EMN, CCC WERA, Bavarian Center for Cancer Research (BZKF), Uniklinikum Erlangen, Erlangen, Germany.
A JägerBiofrontera Bioscience GmbH, Leverkusen, Germany.
B SchmitzBiofrontera Bioscience GmbH, Leverkusen, Germany.
M FoguetBiofrontera Bioscience GmbH, Leverkusen, Germany.
R-M SzeimiesDepartment of Dermatology and Allergology, Vest Clinic, Recklinghausen, Germany.

Funding

Biofrontera Bioscience GmbH
6 · The paper itself

Abstract

backgroundIn actinic keratosis (AK), field cancerization describes areas of skin where multiple visible AK lesions are surrounded by healthy looking skin containing non-visible (subclinical) lesions. As all AK lesions have a risk of progression to cutaneous squamous cell carcinoma, experts advise field-directed treatment. Photodynamic therapy (PDT) is an effective field-directed treatment option for AK; however, long-term efficacy data are still scarce.

objectivesThis publication presents follow-up data of a phase III study evaluating the efficacy and safety of field-directed PDT.

methodsThe study was conducted in seven centres in Germany. For PDT, participants with AKs on the face and scalp (treatment area of 20 cm

resultsFifty-four participants in the BF-200 ALA and 30 in the placebo group entered the follow-up. The probability of a participant to be initially completely cleared and to remain cleared for 12 months was 57.4% for BF-200 ALA versus 20.0% for placebo. The probability of a lesion to be initially cleared and remain cleared for 12 months was 85.4% for BF-200 ALA versus 31.5% for placebo. 83.3% of participants with cosmetic impairment at baseline rated the cosmetic outcome 12 months after PDT with BF-200 ALA as very good or good. All parameters of skin quality further improved during follow-up.

conclusionsWe showed that effectiveness of field-directed PDT with BF-200 ALA and narrow-spectrum red light was maintained during follow-up. Based on our results, field-directed PDT is a beneficial long-lasting treatment for AK patients. CLINICAL TRIAL REGISTRATION NUMBERS: 2013-002510-12 (EudraCT); NCT01966120 (Clinicaltrials.gov).

Indexed as

Aminolevulinic AcidKeratosis, ActinicPhotochemotherapyPhotosensitizing AgentsAgedAged, 80 and overDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedTreatment OutcomeAminolevulinic AcidBF-200 ALAPhotosensitizing Agents

Identifiers

PMID39666443
PMCPMC12291023

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.