Overview

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

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Infectopharm Arzneimittel GmbH
Collaborator:
Gesellschaft für Therapieforschung mbH
Treatments:
Diclofenac