This is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution. In total, 68 patients with actinic keratosis grade I/II, who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated twice daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days. The primary objective is treatment success at the individual end-of-treatment visit of all AK lesions present at baseline and treated with the investigational product. Beside this, adverse events will be collected at each visit and evaluated in order to investigate clinical safety.
Study Type
OBSERVATIONAL
Enrollment
73
Dermatologisches Zentrum
Bonn, Germany
Hautzentrum Dülmen
Dülmen, Germany
Hautärztliche Praxis
Friedrichshafen, Germany
Hautzentrum Nymphenburg
München, Germany
Haut- und Laserzentrum Potsdam
Potsdam, Germany
Hautarzt-Praxis
Stuttgart, Germany
Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator
Treatment success (yes, no) at the individual end-of-treatment visit (VE), defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator, which were present at V0 and treated with the investigational product (complete clearance).
Time frame: Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.