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Prospective, three-arm, randomized, double-blind study according to MPG and AMG on the effectiveness and safety of treating mild to moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo as well as a blinded comparison with diclofenac 3% gel (Solaraze, drug ) [Prospektive, dreiarmige, randomisierte Doppelblind-Studie gemäß MPG und AMG zur Wirksamkeit und Sicherheit der Behandlung der leichten bis moderaten aktinischen Keratose mit einer 5%-igen Kaliumhydroxidlösung (Solcera, Medizinprodukt) versus Placebo sowie untersucherverblindetem Vergleich mit Diclofenac 3% Gel (Solaraze, Arzneimittel)]

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Trial Profile

Prospective, three-arm, randomized, double-blind study according to MPG and AMG on the effectiveness and safety of treating mild to moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo as well as a blinded comparison with diclofenac 3% gel (Solaraze, drug ) [Prospektive, dreiarmige, randomisierte Doppelblind-Studie gemäß MPG und AMG zur Wirksamkeit und Sicherheit der Behandlung der leichten bis moderaten aktinischen Keratose mit einer 5%-igen Kaliumhydroxidlösung (Solcera, Medizinprodukt) versus Placebo sowie untersucherverblindetem Vergleich mit Diclofenac 3% Gel (Solaraze, Arzneimittel)]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs Diclofenac/hyaluronic-acid (Primary) ; Potassium hydroxide
  • Indications Actinic keratosis
  • Focus Registrational; Therapeutic Use
  • Acronyms KOHDIAK
  • Sponsors Infectopharm GmbH

Most Recent Events

  • 02 Mar 2023 Status changed from recruiting to completed.
  • 22 May 2020 New trial record

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