Evidence map›Paper›PMID 40996107›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT.

U Reinhold, N Leitz, R Dominicus, E L Szabó, T Dirschka, G Popp, T C Fischer, N Adamini, R Ostendorf, M Asefi and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04552327 (Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04552327 phase3completednot on this map

Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution (Solcera, Medical Device) Versus Placebo and Investigator-blinded Comparison With 3% Diclofenac Gel (Solaraze, Medicinal Product) (Regulated by the Laws for Both Medical Devices and Medicinal Products)

TypeinterventionalSponsorInfectopharm Arzneimittel GmbHRan2020 to 2023Enrolled631ConditionsActinic KeratosisArmsSolcera, Placebo, Solaraze
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

19 authors.

U ReinholdMVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany.ORCID https://orcid.org/0000-0001-8970-8256
N LeitzHautarztpraxis Dr. Leitz Und Kollegen, Stuttgart, Germany.
R DominicusHautzentrum Dülmen, ProDerma Studieninstitut, Dülmen, Germany.
E L SzabóHautarztzentrum Hamm, Hamm, Germany.
T DirschkaCentroderm GmbH, Wuppertal, Germany.
G PoppDermazentrum Augsburg, Augsburg, Germany.
T C FischerHaut- Und Lasercentrum Potsdam, Potsdam, Germany.
N AdaminiHautpraxis Ibbenbüren, Ibbenbüren, Germany.
R OstendorfZentderma GBR, Mönchengladbach, Germany.
M AsefiDermatologisches Studienzentrum Hunsrück, Simmern, Germany.
H DuraniDurani Cosmetics GmbH, Heidelberg, Germany.
T HöltingHautzentrum Südbaden, Freiburg im Breisgau, Germany.
U AmannHautarztzentrum Lingen, Lingen, Germany.
F KreuzigerHautarztpraxis Vilshofen, Vilshofen an der Donau, Germany.
T AssmannHautzentrum Wuppertal, Wuppertal, Germany.
H BrüningMVZ DermaKiel, Kiel, Germany.
L FreitagHautarztpraxis Dr. L. Freitag & A. Knöll, Falkensee, Germany.
K HoffmannPraxisklinik Dr. Hoffmann, Lohne, Germany.
R GedscholdInfectoPharm Arzneimittel Und Consilium GmbH, Heppenheim, Germany.ORCID https://orcid.org/0009-0000-9615-3412

Funding

InfectoPharm Arzneimittel und Consilium GmbH
6 · The paper itself

Abstract

backgroundActinic Keratosis (AK) has the potential to progress into malignant cancer, thus necessitating timely and effective treatment. Despite several existing therapies, there is still a need for effective, well-tolerated therapeutic options, especially in the early treatment of patients with few isolated lesions in primary care.

objectivesTo investigate the efficacy and safety of potassium hydroxide (KOH) 5% solution in comparison to diclofenac 3% gel and placebo for the treatment of mild-to-moderate AK.

methodsIn this randomized controlled trial, patients with mild or moderate AK applied KOH or placebo solution double-blinded twice daily for 28 days, followed by a 28-day off-treatment phase (1 treatment cycle) for up to three treatment cycles or until treatment success. In a third arm, diclofenac was applied twice daily for 60 days and evaluated investigator-blinded. The primary endpoint was treatment success, defined as complete clearance (CC) of all initially present AK lesions per patient at the end of treatment (EOT).

resultsIn total, 631 patients were enrolled. Treatment success was achieved by 45.2% of patients treated with KOH, compared to 23.8% and 22.9% with diclofenac and placebo, respectively. Similarly, complete remission rates for individual lesions were higher with KOH (65.0%) than with diclofenac (45.9%) or placebo (39.9%). KOH showed a faster onset of action, with higher CC rates already after 1 month compared to diclofenac (16.0% vs. 9.2%) and converging efficacies after 6 months. Most adverse reactions were mild and localized, with comparable tolerability of KOH and diclofenac.

conclusionsKOH 5% solution proved superior to placebo and, when compared to diclofenac 3% gel, demonstrated significantly higher efficacy at EOT, as well as faster onset of action with comparable long-term efficacy and tolerability. KOH 5% solution is a valuable addition to the available treatment options for lesion-directed therapy in patients with mild-to-moderate AK. CLINICALTRIALS: GOV IDENTIFIER: NCT04552327.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalDiclofenacHydroxidesKeratosis, ActinicPotassium CompoundsAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalDiclofenacHydroxidesPotassium Compoundspotassium hydroxideactinic keratosisdiclofenaclesion‐directed therapypotassium hydroxide

Identifiers

PMID40996107
PMCPMC13206550

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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.