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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04024579
Study type Observational
Source Infectopharm Arzneimittel GmbH
Contact
Status Completed
Phase
Start date October 17, 2017
Completion date August 25, 2019

See also
  Status Clinical Trial Phase
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