Evidence map›Paper›PMID 41187222›Full record

Trial reportPhotodermatology, photoimmunology & photomedicine2025

Can Urea 10% Promote Photosensitizer Uptake Before MAL-PDT for the Treatment of Facial Actinic Keratoses? Results of a Randomized Clinical Trial.

Grazia Linda Artelli, Isacco Cattaneo, Luca Rubelli, Cesare Ariasi, Stefano Bighetti, Cesare Tomasi, Gaetano Licata, Simone Soglia, Piergiacomo Calzavara-Pinton, Mariachiara Arisi

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Photodermatology, photoimmunology & photomedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Trial
  2. 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

10 authors.

Grazia Linda ArtelliDepartment of Dermatology, University of Brescia, Brescia, Italy.
Isacco CattaneoDepartment of Dermatology, University of Brescia, Brescia, Italy.ORCID https://orcid.org/0009-0009-2307-2406
Luca RubelliDepartment of Dermatology, University of Brescia, Brescia, Italy.ORCID https://orcid.org/0009-0005-3192-4059
Cesare AriasiDepartment of Dermatology, University of Brescia, Brescia, Italy.
Stefano BighettiDepartment of Dermatology, University of Brescia, Brescia, Italy.ORCID https://orcid.org/0009-0006-2781-6909
Cesare TomasiDepartment of Experimental and Applied Medicine, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.
Gaetano LicataDepartment of Dermatology, Sant'antonio Abate Hospital, Trapani, Italy.
Simone SogliaDepartment of Dermatology, University of Brescia, Brescia, Italy.
Piergiacomo Calzavara-PintonDepartment of Dermatology, University of Brescia, Brescia, Italy.ORCID https://orcid.org/0000-0002-0935-7204
Mariachiara ArisiDepartment of Dermatology, University of Brescia, Brescia, Italy.

Funding

La Roche Posay
6 · The paper itself

Abstract

backgroundActinic keratoses (AKs) are precancerous lesions that may progress to squamous cell carcinoma (SCC). Photodynamic therapy (PDT) with methyl aminolevulinate (MAL) is an established treatment, often preceded by mechanical curettage to enhance photosensitizer penetration. However, curettage is associated with pain and discomfort, necessitating alternative pretreatment strategies, also applicable in daylight PDT.

methodsThirty-six patients with symmetrical facial AKs were randomized to receive MAL-PDT on two contralateral areas: one pretreated with a 10% urea-based keratolytic compound (UBC) for 14 days and the other untreated (control). Protoporphyrin IX (PpIX) fluorescence, clinical outcomes, cosmetic results, and patient satisfaction were assessed. Statistical analyses included the Wilcoxon, Mann-Whitney, and chi-squared tests (p ≤ 0.05).

resultsThe urea-pretreated group showed significantly higher fluorescence intensity (median: 7 [5-9]) vs. controls (median: 5 [3-6]; **p < 0.0001**), indicating improved MAL penetration. Both groups had significant AK reductions (**p = 0.02**). The reduction in Olsen grade I AKs was greater with UBC (**p < 0.0001**), while no significant differences were observed for grade II lesions. Tolerability and patient satisfaction were high, with no significant differences in pain scores, local skin reactions, or cosmetic outcomes.

conclusionsPretreatment with a 10% UBC enhances PpIX fluorescence and improves efficacy in grade I AKs when compared to no pretreatment. Thus, it provides a non-invasive pretreatment option with good efficacy in thin AKs, along with good patient satisfaction and safety.

Indexed as

Aminolevulinic AcidKeratosis, ActinicPhotochemotherapyPhotosensitizing AgentsUreaAgedAged, 80 and overFemaleHumansMaleMiddle AgedPatient SatisfactionProtoporphyrinsAminolevulinic Acidmethyl 5-aminolevulinatePhotosensitizing Agentsprotoporphyrin IXProtoporphyrinsUreaactinic keratoses (AKs)keratolytic pretreatmentMAL‐PDTmethyl aminolevulinate (MAL)photodynamic therapy (PDT)

Identifiers

PMID41187222
PMCPMC12585119

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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.