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Treatment of Actinic Keratosis With 5% KOH Solution

NCT04024579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2019-10-22

No results posted yet for this study

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

Sponsors & Collaborators

  • Gesellschaft für Therapieforschung mbH

    collaborator INDUSTRY

  • Infectopharm Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Dietrich Abeck, Prof. · Professor of dermatology and allergology

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2019-08-25
Completion
2019-08-25

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04024579 on ClinicalTrials.gov