NCT04552327

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 631 (actual)
• Sponsor: Infectopharm Arzneimittel GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DEVICE	Solcera	Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
DEVICE	Placebo	Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
DRUG	Solaraze	Twice daily application for a duration of 60 days

Timeline

• Start date: 2020-10-14
• Primary completion: 2023-01-24
• Completion: 2023-01-24
• First posted: 2020-09-17
• Last updated: 2024-03-05

Locations

18 sites across 1 country: Germany