Actinic Keratoses Clinical Trial
Official title:
Prospective, Single-arm, Medical Device Investigation According to § 23b MPG [German Medical Devices Act] on Efficacy and Safety of Treatment of Actinic Keratosis With a 5% Potassium Hydroxide Solution (AKOHDerm)
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.
n/a
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