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

Photodynamic therapy (pdt) for skin rejuvenation: A pilotstudy evaluating the effectiveness of two modalities of photodynamic therapy in the treatment of photodamaged skin - ST-PDT vs. DL-PDT in treatment of photodamage

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003626-32-AT

Enrollment

Registered

2017-11-16

Start date

2018-02-06

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Photodamaged skin MedDRA version: 20.0 Level: PT Classification code 10068388 Term: Actinic elastosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Ameluz Product Name: Ameluz Product Code: EMEA/H/C/002204-N/005 Pharmaceutical Form: Gel INN or Proposed INN: 5-aminolaevulinic acid CAS Number: 5451-09-2 Other descriptive name: AMINOLEVU

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparing the effects of standard PDT vs. daylight PDT in patients with photodamaged skin on changes in visible 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.	—

Measure

Time frame

Main Objective: Comparing the effects of standard PDT vs. daylight PDT in patients with photodamaged skin on changes in visible 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.

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Secondary

Measure	Time frame
Secondary end point(s): Skin changes as measured with reflectance confocal microscopy and ultrasound, local phototoxic reaction, tolerability and patient 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 Lokale phototoxische Reaktionen 10, 30 min sowie 7 Tage nach PDT Behandlungsassoziierte Schmerzen während der Standard PDT nach 1,5,10 Minuten sowie 10 und 30min nach Therapieende Behandlungsassoziierte Schmerzen während der Daylight PDT nach 1,30,60,90,120 Minuten sowie 10 und 30min nach Therapieende Evaluierung der Patientenzufriedenheit, 3 und 6 Monate nach der Therapiebeginn	—

Measure

Time frame

Secondary end point(s): Skin changes as measured with reflectance confocal microscopy and ultrasound, local phototoxic reaction, tolerability and patient 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 Lokale phototoxische Reaktionen 10, 30 min sowie 7 Tage nach PDT Behandlungsassoziierte Schmerzen während der Standard PDT nach 1,5,10 Minuten sowie 10 und 30min nach Therapieende Behandlungsassoziierte Schmerzen während der Daylight PDT nach 1,30,60,90,120 Minuten sowie 10 und 30min nach Therapieende Evaluierung der Patientenzufriedenheit, 3 und 6 Monate nach der Therapiebeginn

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Countries

Austria

Contacts

Public ContactUniv. Klinik fuer Dermatologie

Medizinische Universitaet Wien, Univ. Klinik fuer Dermatologie

sonja.radakovic@meduniwien.ac.at+4314040077020

Outcome results

None listed

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