Evidence map›Paper›PMID 29070025›Full record

Trial reportBMC dermatology2017

Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study.

E Kohl, M Koller, F Zeman, R-M Szeimies, W G Philipp-Dormston, W Prager, P A Gerber, S Karrer

Registry-linked trialOpen access · diamondAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02736760 (Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face), 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
2.2field-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.

NCT02736760 phase4completednot on this map

Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face

TypeinterventionalSponsorUniversity Hospital RegensburgRan2016 to 2018Enrolled58ConditionsActinic Keratoses, Photodamaged SkinArmsDaylight photodynamic therapy using Methylaminolevulinate (MAL), Cryosurgery
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. 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

8 authors at 4 institutions in 1 country.

E KohlDepartment of Dermatology, University Hospital Regensburg, 93042, Regensburg, Germany.
M KollerCenter for Clinical Studies, University Hospital Regensburg, 93042, Regensburg, Germany.
F ZemanCenter for Clinical Studies, University Hospital Regensburg, 93042, Regensburg, Germany.
R-M SzeimiesDepartment of Dermatology and Allergology, Vest Hospital, Academic Teaching Hospital University of Bochum, 45657, Recklinghausen, Germany.
W G Philipp-DormstonHautzentrum Köln, 50966, Köln, Germany.
W PragerPrager & Partner, 22609, Hamburg, Germany.
P A GerberDepartment of Dermatology, Medical Faculty, Heinrich-Heine University, 40225, Düsseldorf, Germany.
S KarrerDepartment of Dermatology, University Hospital Regensburg, 93042, Regensburg, Germany. sigrid.karrer@ukr.de.
University Hospital Regensburg · DEDeutz (Germany) · DEHeinrich Heine University Düsseldorf · DEUniversity Hospitals of the Ruhr-University of Bochum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPhotodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the efficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin has not yet been investigated. METHODS/

designIn this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial, patients with a minimum of 5 mild-to-moderate AK lesions on photodamaged facial skin are randomly allocated to two treatment groups: DL-PDT with methyl aminolevulinate (MAL) and cryosurgery. In the DL-PDT group (experimental group), 5 treatments of the entire face are conducted over the course of 18 months. After preparation of the lesion and within 30 min after MAL application, patients expose themselves to daylight for 2 h. In the control group, lesion-directed cryosurgery is conducted at the first visit and, in the case of uncleared or new AK lesions, also at visits 2 to 5. The efficacy of the treatment is evaluated at visits 2 to 6 by documenting all existing and new AK lesions in the face. Cosmetic results and improvement of photoaging parameters are evaluated by means of a modified Dover scale. Primary outcome parameter is the cumulative number of AK lesions observed between visits 2 and 6. Secondary outcome parameters are complete clearance of AK, new AK lesions since the previous visit, cosmetic results independently evaluated by both patient and physician, patient-reported pain (visual analogue scale), patient and physician satisfaction scores with cosmetic results, and patient-reported quality of life (Dermatology Life Quality Index). Safety parameters are also documented (adverse events and serious adverse events). DISCUSSION: This clinical trial will assess the efficacy of repetitive DL-PDT in preventing AK and investigate possible rejuvenating effects of this treatment. (Trial registration: ClinicalTrials.gov Identifier: NCT02736760).

trial registrationClinicalTrials.gov Identifier: NCT02736760 . Study Code Daylight_01. EudraCT 2014-005121-13.

Indexed as

CryosurgeryPhotochemotherapyAdultAminolevulinic AcidFemaleHumansIntention to Treat AnalysisKeratosis, ActinicMaleResearch DesignSingle-Blind MethodSunlightAminolevulinic Acidmethyl 5-aminolevulinateAKCryosurgeryDaylightMethyl aminolevulinatePDTPhotorejuvenationPreventionSkin agingStudy protocol

Identifiers

PMID29070025
PMCPMC5657041
OpenAlexW2765880918

What OpenQuestion holds

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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.