Academic Journal
KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT.
| Τίτλος: | KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT. |
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| Συγγραφείς: | Reinhold U; MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany., Leitz N; Hautarztpraxis Dr. Leitz Und Kollegen, Stuttgart, Germany., Dominicus R; Hautzentrum Dülmen, ProDerma Studieninstitut, Dülmen, Germany., Szabó EL; Hautarztzentrum Hamm, Hamm, Germany., Dirschka T; Centroderm GmbH, Wuppertal, Germany., Popp G; Dermazentrum Augsburg, Augsburg, Germany., Fischer TC; Haut- Und Lasercentrum Potsdam, Potsdam, Germany., Adamini N; Hautpraxis Ibbenbüren, Ibbenbüren, Germany., Ostendorf R; Zentderma GBR, Mönchengladbach, Germany., Asefi M; Dermatologisches Studienzentrum Hunsrück, Simmern, Germany., Durani H; Durani Cosmetics GmbH, Heidelberg, Germany., Hölting T; Hautzentrum Südbaden, Freiburg im Breisgau, Germany., Amann U; Hautarztzentrum Lingen, Lingen, Germany., Kreuziger F; Hautarztpraxis Vilshofen, Vilshofen an der Donau, Germany., Assmann T; Hautzentrum Wuppertal, Wuppertal, Germany., Brüning H; MVZ DermaKiel, Kiel, Germany., Freitag L; Hautarztpraxis Dr. L. Freitag & A. Knöll, Falkensee, Germany., Hoffmann K; Praxisklinik Dr. Hoffmann, Lohne, Germany., Gedschold R; InfectoPharm Arzneimittel Und Consilium GmbH, Heppenheim, Germany. |
| Πηγή: | Journal of the European Academy of Dermatology and Venereology : JEADV [J Eur Acad Dermatol Venereol] 2026 Jun; Vol. 40 (6), pp. 1050-1058. Date of Electronic Publication: 2025 Sep 25. |
| Τύπος έκδοσης: | Journal Article; Randomized Controlled Trial; Comparative Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9216037 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1468-3083 (Electronic) Linking ISSN: 09269959 NLM ISO Abbreviation: J Eur Acad Dermatol Venereol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Oxford : Wiley-Blackwell Original Publication: Amsterdam ; New York : Elsevier Science Publishers, c1992- |
| Ιατρικοί όροι (MeSH): | Diclofenac*/therapeutic use , Diclofenac*/adverse effects , Diclofenac*/administration & dosage , Keratosis, Actinic*/drug therapy , Hydroxides*/therapeutic use , Hydroxides*/adverse effects , Hydroxides*/administration & dosage , Potassium Compounds*/therapeutic use , Potassium Compounds*/adverse effects , Potassium Compounds*/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal*/therapeutic use, Humans ; Male ; Female ; Double-Blind Method ; Aged ; Middle Aged ; Treatment Outcome ; Aged, 80 and over |
| Περίληψη: | Background: Actinic 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. Objectives: To 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. Methods: In 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). Results: In 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. Conclusions: KOH 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. Gov Identifier: NCT04552327. (© 2025 The Author(s). Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.) |
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| Grant Information: | InfectoPharm Arzneimittel und Consilium GmbH |
| Contributed Indexing: | Keywords: actinic keratosis; diclofenac; lesion‐directed therapy; potassium hydroxide Local Abstract: [plain-language-summary] Repeatedly sun‐damaged skin can develop rough, scaly patches called actinic keratosis, which may eventually develop into skin cancer. In a trial with 631 adult patients at German medical centers, researchers tested whether a potassium hydroxide (KOH) solution could treat these patches compared to an often‐used standard therapy and to an inactive control (placebo). The results show that KOH solution is effective and safe in the therapy of early‐stage disease and quickly produces noticeable results. This makes KOH a useful option when choosing treatments for patients with early signs of actinic keratosis. |
| Molecular Sequence: | ClinicalTrials.gov NCT04552327 |
| Substance Nomenclature: | 144O8QL0L1 (Diclofenac) WZH3C48M4T (potassium hydroxide) 0 (Hydroxides) 0 (Potassium Compounds) 0 (Anti-Inflammatory Agents, Non-Steroidal) |
| Entry Date(s): | Date Created: 20250925 Date Completed: 20260525 Latest Revision: 20260813 |
| Update Code: | 20260813 |
| PubMed Central ID: | PMC13206550 |
| DOI: | 10.1111/jdv.70069 |
| PMID: | 40996107 |
| Βάση Δεδομένων: | MEDLINE |
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