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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015749

Enrollment

Registered

2018-12-04

Start date

2019-04-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L57.0

Interventions

Group 1: Treatment of actinic keratoses of the scalp with conventional PDT (c-PDT). Incubation time 3 hours, approx 10 minutes illumination with a redlight LED lamp System. Group 2: Treatment of actin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
difference in systolic blood pressure (SBP after PDT- SBP prePDT) measured non invasively with a blood pressure monitor	—

Secondary

Measure	Time frame
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 differences in mean arterial pressure (value post PDT- value pre PDT) calculated from DBP and SBP 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. Differences in mean pain pre- and immediately post-PDT determined by questionnaire (VAS Score)	—

Measure

Time frame

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 differences in mean arterial pressure (value post PDT- value pre PDT) calculated from DBP and SBP 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. Differences in mean pain pre- and immediately post-PDT determined by questionnaire (VAS Score)

—

Countries

Germany

Contacts

Public ContactPatrick Gholam

Universitätshautklinik Heidelberg

patrick.gholam@med.uni-heidelberg.de+49/6221/56-8576

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026