NCT04024579

Treatment of Actinic Keratosis With 5% KOH Solution

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Infectopharm Arzneimittel GmbH · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratoses

Timeline

• Start date: 2017-10-17
• Primary completion: 2019-08-25
• Completion: 2019-08-25
• First posted: 2019-07-18
• Last updated: 2019-10-22

Locations

6 sites across 1 country: Germany