ALA-PDT without vs ALA-PDT in combination with occlusion in patients with actinic keratosis

The influence of occlusive application of 5-aminolaevulinic acid (ALA) on the efficacy of photodynamic therapy for actinic keratosis - PDT vs PDT and translucent bandage in patients with AK

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003331-18-AT

Enrollment

Registered

2014-11-24

Start date

2014-12-17

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

non melanoma skin cancer MedDRA version: 17.1 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-Aminolevulinic acid CAS Number: 33320-16-0 Other descriptive name: METHYL AM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with clinically confirmed actinic keratosis in the face and scalp Age 18 years or older 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Known allergy to aminlevulinic acid Patients with porphyria or taking photosensitizing drugs Patients with severe compromised general state Patients who are participating in another study Patients unable to stick to the study protocol Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: The influence of occlusive application of 5-aminolaevulinic acid on the efficacy of photodynamic therapy in patients with actinic keratosis;Secondary Objective: To compare the tolerability , relapse rate , local phototoxic reaction and cosmetic results of occlusive application of 5-aminolaevulinic acid on the efficacy of photodynamic therapy in patients with actinic keratosis;Primary end point(s): Complete clearance of actinic keratosis 3 months after completion of treatment;Timepoint(s) of evaluation of this end point: Clinical control after 3 months after treatment with PDT with or without occlusive application	—

Measure

Time frame

Main Objective: The influence of occlusive application of 5-aminolaevulinic acid on the efficacy of photodynamic therapy in patients with actinic keratosis;Secondary Objective: To compare the tolerability , relapse rate , local phototoxic reaction and cosmetic results of occlusive application of 5-aminolaevulinic acid on the efficacy of photodynamic therapy in patients with actinic keratosis;Primary end point(s): Complete clearance of actinic keratosis 3 months after completion of treatment;Timepoint(s) of evaluation of this end point: Clinical control after 3 months after treatment with PDT with or without occlusive application

—

Secondary

Measure	Time frame
Secondary end point(s): The recurrence rate of actinic keratosis at 6 months after completion of the therapy as well as tolerability , local phototoxic reaction and cosmetic response in both groups;Timepoint(s) of evaluation of this end point: The recurrence rate of actinic keratosis at 6 months after completion of therapy Cosmetic response 6 months after completion of therapy Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days after therapy Tolerability 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): The recurrence rate of actinic keratosis at 6 months after completion of the therapy as well as tolerability , local phototoxic reaction and cosmetic response in both groups;Timepoint(s) of evaluation of this end point: The recurrence rate of actinic keratosis at 6 months after completion of therapy Cosmetic response 6 months after completion of therapy Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days after therapy Tolerability 1,5,10 minutes after the beginning as well as 10 and 30 minutes after finishing the therapy

—

Countries

Austria

Contacts

Public ContactUniv. Klinik für Dermatologie

Medizinische Universität Wien, Univ. Klinik für Dermatologie

sonja.radakovic@meduniwien.ac.at+4314040077020

Outcome results

None listed

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