5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis

Summary

The KOHDIAK study is a 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). It is performed in accordance with both the laws in force for clinical trials with medical devices and those with medicinal products.

Timeline

Start

2020-10-14

Primary completion

2023-01-24

Completion

2023-01-24

Publications

• Reinhold U, Leitz N, Dominicus R, Szabo EL, Dirschka T, Popp G, Fischer TC, Adamini N, Ostendorf R, Asefi M, Durani H, Holting T, Amann U, Kreuziger F, Assmann T, Bruning H, Freitag L, Hoffmann K, Gedschold R. KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1050-1058. doi: 10.1111/jdv.70069. Epub 2025 Sep 25.

Drugs

Indications