Photodynamic therapy for skin rejuvenation: A study comparing two different methods for the treatment of sundamaged ski

Phase 1

Conditions: Photodamaged skin
MedDRA version: 20.0Level: PTClassification code 10068388Term: Actinic elastosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2017-003626-32-AT

Lead Sponsor: Medizinische Universität Wien, Univ. Klinik f. Dermatologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients between 50 and 85 with photodamaged skin and a photoaging score of 8 or more as well as skin type I-III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Known allergy to aminlevulinic acid
Patients with porphyria or taking photosensitizing drugs
Patients with severe compromised general state
Patients with other dermatological diseases in the treatment area
Patient with another skin rejuvenation treatment in the last 6 moths
Patients unable to stick to the study protocol
Pregnant or lactating women
Patients who are participating in another study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparing the effects of standard PDT vs. daylight PDT in patients with photodamaged skin on changes in visible<br>skin aging. The changes will be determined by a clinical photoaging score 6 months after treatment.;Secondary Objective: Evaluation and comparison of the effects of the two methods 6 months after treatment on skin quality and signs of photoageing as measured with reflectance confocal microscopy and skin ultrasound; pain intensity, local phototoxic reaction; patients satisfaction ;Primary end point(s): Changes of the Photoaging Score;Timepoint(s) of evaluation of this end point: Clinical control 6 months after treatment with both PDT , DL-PDT and ST-PDT.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Skin changes as measured with reflectance confocal microscopy and ultrasound, local phototoxic reaction, tolerability and patient<br>satisfaction 3 and 6 moths after treatment;Timepoint(s) of evaluation of this end point: Veränderungen der Haut gemessen durch konfokale Mikroskopie und Ultraschall 3 und 6 Monate nach Therapiebeginn<br>Lokale phototoxische Reaktionen 10, 30 min sowie 7 Tage nach PDT<br>Behandlungsassoziierte Schmerzen während der Standard PDT nach 1,5,10 Minuten sowie 10 und 30min nach Therapieende<br>Behandlungsassoziierte Schmerzen während der Daylight PDT nach 1,30,60,90,120 Minuten sowie 10 und 30min nach Therapieende<br>Evaluierung der Patientenzufriedenheit, 3 und 6 Monate nach der Therapiebeginn