Spots Global Cancer Trial Database for 5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis

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Trial Identification

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

Official Title: 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)

Study ID: NCT04552327

Conditions

Actinic Keratosis

Interventions

Solcera

Placebo

Solaraze

Study Description

Brief 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.

Detailed Description: