Hemodynamic changes during conventional and daylight photodynamic therapy of actinic keratoses - a randomized controlled trial

Not Applicable

• Conditions: L57.0; Actinic keratosis

• Registration Number: DRKS00015749
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-04
• Study Completion: 2021-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

clinically or histologically confirmed diagnosis of actinic keratoses; three or more AK located in one treatment area on the face or scalp; Age of at least 18 years; signed informed consent; ability to consent

Exclusion Criteria

intolerance to components of the photosensitizer (Metvix); diagnosis of porphyria; pregnancy or lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference in systolic blood pressure (SBP after PDT- SBP prePDT) measured non invasively with a blood pressure monitor

Secondary Outcome Measures

Name	Time	Method
differences in mean diastolic blood pressure, mean pulse rate, mean Oxygen Saturation (values post PDT - values pre PDT) measured non-invasively with a blood pressure monitor and pulsometer<br><br>differences in mean arterial pressure (value post PDT- value pre PDT) calculated from DBP and SBP<br><br>differences in mean AK reduction (percent) calculated from (AK number pre PDT- AK number 1 month post PDT)/AK number pre PDT. AK numbers are determined by clinical examination.<br><br>Differences in mean pain pre- and immediately post-PDT determined by questionnaire (VAS Score)