ALA-PDT with different light doses in patients with actinic keratoses

Impact of light dose on the efficacy of Photodynamic therapy with 5-aminolaevulinic acid (5-ALA) and a 635 +- 9nm emitting LED-lamp for the treatment of actinic keratoses - a randomized, observer-blinded, intraindividual trial - Different light doses ALA-PDT AKs

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002245-66-AT

Enrollment

Unknown

Registered

2015-11-30

Start date

2015-12-30

Completion date

Unknown

Last updated

2016-06-13

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

Conditions

Actinic keratoses (AK) as precursors of squamous cell carcinoma (SCC) of the skin MedDRA version: 19.0 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-aminolevulinic acid hydrochloride CAS Number: 106-60-5 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 years and = 90 years Patients with at least 4-8 actinic keratosis in the face and/or scalp Olsen stage I-II Distance between lesions should be about 1 cm Size of lesions >0,5 and =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Actinic keratoses with Olsen stage> II Photodermatoses like Porphyria cutanea tarda, PLE or Xeroderma pigmentosum Diseases that will be aggravated by light, e.g. lupus erythematodes Porphyria or intake of photosensitizing drugs Known allergy to aminlevulinic acid specific treatment during the last 4 weeks Patients with severe compromised general state Participation in another clinical trial Patients unable to stick to the study protocol Patients not able to give written informed consent Pregnant or lactating women skin type V-VI allergy against peanuts or soya

Design outcomes

Primary

Measure	Time frame
Main Objective: Clearance of actinic keratoses 12 weeks after last Photodynamic treatment (PDT) with different light doses and/or fluence rates ;Secondary Objective: Tolerability (pain), relapse rate, cosmetic outcome, local phototoxic reaction, global patient satisfaction ;Primary end point(s): Complete clearance of actinic keratosis 12 weeks after completion of treatment;Timepoint(s) of evaluation of this end point: 12 weeks after last PDT	—

Measure

Time frame

Main Objective: Clearance of actinic keratoses 12 weeks after last Photodynamic treatment (PDT) with different light doses and/or fluence rates ;Secondary Objective: Tolerability (pain), relapse rate, cosmetic outcome, local phototoxic reaction, global patient satisfaction ;Primary end point(s): Complete clearance of actinic keratosis 12 weeks after completion of treatment;Timepoint(s) of evaluation of this end point: 12 weeks after last PDT

—

Secondary

Measure	Time frame
Secondary end point(s): Tolerability (pain), relapse rate, cosmetic outcome, local phototoxic reaction, global patient satisfaction ;Timepoint(s) of evaluation of this end point: - pain: during treatment, at the end of treatment, 10 minutes, 2 days and 7 days after treatment - relapse rate: 24 weeks after last PDT - local photoxic reaction: immediate assessment at the end of the treatment, 10 minutes, 2 days and 7 days after treatment - cosmetic outcome: 12 and 24 weeks after last PDT - global patient satisfaction: 12 and 24 weeks after last PDT	—

Measure

Time frame

Secondary end point(s): Tolerability (pain), relapse rate, cosmetic outcome, local phototoxic reaction, global patient satisfaction ;Timepoint(s) of evaluation of this end point: - pain: during treatment, at the end of treatment, 10 minutes, 2 days and 7 days after treatment - relapse rate: 24 weeks after last PDT - local photoxic reaction: immediate assessment at the end of the treatment, 10 minutes, 2 days and 7 days after treatment - cosmetic outcome: 12 and 24 weeks after last PDT - global patient satisfaction: 12 and 24 weeks after last PDT

—

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