Evidence map›Paper›PMID 38457386›Full record

Trial reportPloS one2024

New, simplified versus standard photodynamic therapy (PDT) regimen for superficial and nodular basal cell carcinoma (BCC): A single-blind, non-inferiority, randomised controlled multicentre study.

Eidi Christensen, Erik Mørk, Olav Andreas Foss, Cato Mørk, Susanne Kroon, Lars Kåre Dotterud, Per Helsing, Øystein Vatne, Eirik Skogvoll, Patricia Mjønes and 1 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Photodynamic Therapy in Dermatology.International journal of molecular sciences · 2026
    Review
  3. Article
  4. Review
  5. Review
  6. Article
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

11 authors at 7 institutions in 1 country.

Eidi ChristensenDepartment of Dermatology, Clinic of Orthopaedics, Rheumatology and Dermatology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.ORCID 0000-0002-6848-9290
Erik MørkFaculty of Medicine, Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.ORCID 0000-0002-6493-297X
Olav Andreas FossOrthopaedic Research Centre, Clinic of Orthopaedics, Rheumatology and Dermatology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
Cato MørkAkershus Dermatology Centre, Lørenskog, Norway.
Susanne KroonDepartment of Dermatology and Venerology, Stavanger University Hospital, Stavanger, Norway.
Lars Kåre DotterudLillehammer Dermatology Centre, Lillehammer, Norway.
Per HelsingDepartment of Dermatology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Øystein VatneDepartment of Dermatology, Førde Central Hospital, Førde, Norway.
Eirik SkogvollFaculty of Medicine, Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.
Patricia MjønesFaculty of Medicine, Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
Ingeborg Margrethe BachmannDepartment of Clinical Medicine, University of Bergen, Bergen, Norway.
Norwegian University of Science and Technology · NOAkershus University Hospital · NOHaukeland University Hospital · NOHelse Førde · NOOslo University Hospital · NOStavanger University Hospital · NOSt Olav's University Hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical photodynamic therapy (PDT) is an approved and widely used treatment for low-risk basal cell carcinoma (BCC), comprising two sessions with an interval of 1 week. Simplification of the treatment course can be cost-effective, easier to organize, and cause less discomfort for the patients. METHODS AND

findingsWe performed an investigator-initiated, single-blind, non-inferiority, randomized controlled multicentre study with the objective of investigating whether a simpler and more flexible PDT regimen was not >10% less effective than the standard double PDT in the treatment of primary, superficial, and nodular ≤2 mm-thick BCC and evaluate the cosmetic outcome. With a non-inferiority margin of 0.1 and an expected probability complete response of 0.85, 190 tumours were required in each group. Histologically verified BCCs from seven centres in Norway were randomly assigned (1:1) to either receive a new regimen of single PDT with one possible re-treatment of non-complete responding tumours, or the standard regimen. The primary endpoint was the number of tumours with complete response or treatment failure at 36 months of follow-up, assessed by investigators blinded to the treatment regimen. Intention-to-treat and per-protocol analyses were performed. The cosmetic outcome was recorded. The study was registered with ClinicalTrials.gov, NCT-01482104, and EudraCT, 2011-004797-28. A total of 402 BCCs in 246 patients were included; 209 tumours assigned to the new and 193 to the standard regimen. After 36 months, there were 61 treatment failures with the new and 34 failures with the standard regimen. Complete response rate was 69.5% in the new and 81.1% in the standard treatment group. The difference was 11.6% (upper 97.5% CI 20.3), i.e. > than the non-inferiority margin of 10%. Cosmetic outcomes were excellent or good in 92% and 89% following the new and standard regimens, respectively.

conclusionsSingle PDT with possible re-treatment of primary, superficial, and nodular ≤ 2-mm-thick BCC was significantly less effective than the approved standard double treatment. The cosmetic outcome was favorable and comparable between the two treatment groups.

Indexed as

Basal Cell CarcinomaPhotochemotherapySkin NeoplasmsAminolevulinic AcidHumansPathologic Complete ResponsePhotosensitizing AgentsSingle-Blind MethodTreatment OutcomeAminolevulinic AcidPhotosensitizing Agents

Identifiers

PMID38457386
PMCPMC10923430
OpenAlexW4392582645

What OpenQuestion holds

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Registered trials

None linked

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.