Conventional versus fractional Er:YAG Laser-assisted low irradiance photodynamic therapy in the treatment of actinic keratosis and field cancerization - a randomized controlled trial

Not Applicable

• Conditions: field cancerization; L57.0; Actinic keratosis

• Registration Number: DRKS00021665
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Study Completion: 2021-08-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Clinically or histologically confirmed diagnosis of actinic keratoses; AK or field cancerization located in at least two comparable treatment areas on the face or scalp; Age of at least 18 years; Ability to give consent; Signed informed consent

Exclusion Criteria

Intolerance to components of the photosensitizer (Metvix®) or topical anaesthesia (EMLA®); Diagnosis of porphyria; Pregnancy or lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean lesion response rate 3 months post PDT<br>(For this purpose, the mean lesional response rate of all patients in the group is calculated. The lesional response rate of a single patient is calculated on the Basis of the difference between the AK before PDT and after PDT in relation to the number of AK before PDT.)

Secondary Outcome Measures

Name	Time	Method
AKASI score reduction<br>mean pain (VAS)<br>mean number of therapy interruptions