Photodynamic therapy for skin rejuvenation: A pilotstudy using LED light and the substance 5-aminolevulinic acid

Photodynamic therapy for skin rejuvenation: A pilotstudy evaluating the effectiveness of 5-aminolevulinic acid -based photodynamic therapy in the treatment of photodamaged skin - PDT with LED in treatment of photodamage

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002537-22-AT

Enrollment

Registered

2016-12-23

Start date

2017-01-25

Completion date

Unknown

Last updated

2018-02-12

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

Conditions

Photodamaged skin MedDRA version: 19.1 Level: PT Classification code 10068388 Term: Actinic elastosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.1 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 40 and 80 with photodamaged skin and a photoaging Score of 4 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

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: Evaluating the effectiveness of ALA-PDT in patients with photodameged skin concerning cosmetic results and the change of skin quality and skinaging 6 months after treatment;Secondary Objective: To evaluate the change of skin thickness ,tolerability , local phototoxic reaction after PDT with with LED light and atients satisfaction in patients with photodamaged skin 6 moths after treatment;Primary end point(s): Changes of the Photoaging Score;Timepoint(s) of evaluation of this end point: Clinical control 3 and 6 months after treatment with PDT with LED	—

Measure

Time frame

Main Objective: Evaluating the effectiveness of ALA-PDT in patients with photodameged skin concerning cosmetic results and the change of skin quality and skinaging 6 months after treatment;Secondary Objective: To evaluate the change of skin thickness ,tolerability , local phototoxic reaction after PDT with with LED light and atients satisfaction in patients with photodamaged skin 6 moths after treatment;Primary end point(s): Changes of the Photoaging Score;Timepoint(s) of evaluation of this end point: Clinical control 3 and 6 months after treatment with PDT with LED

—

Secondary

Measure	Time frame
Secondary end point(s): Skin thickness, local phototoxic reaction, tolerability and patient satisfaction 3 and 6 moths after treatment;Timepoint(s) of evaluation of this end point: skin thickness 3 and 6 months after treatment Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days after therapy Tolerability (pain) 1,5,10 minutes after the beginning as well as 10 and 30 minutes after finishing the therapy	—

Measure

Time frame

Secondary end point(s): Skin thickness, local phototoxic reaction, tolerability and patient satisfaction 3 and 6 moths after treatment;Timepoint(s) of evaluation of this end point: skin thickness 3 and 6 months after treatment Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days after therapy Tolerability (pain) 1,5,10 minutes after the beginning as well as 10 and 30 minutes after finishing the therapy

—

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