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

Phase 1

Conditions: non melanoma skin cancer
MedDRA version: 17.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-003331-18-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: 45

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The recurrence rate of actinic keratosis at 6 months after completion of<br>the therapy as well as tolerability , local phototoxic reaction and<br>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<br>Cosmetic response 6 months after completion of therapy<br>Local phototoxic reaction 10 and 30 minutes as well as 2 and 7 days<br>after therapy<br>Tolerability 1,5,10 minutes after the beginning as well as 10 and 30<br>minutes after finishing the therapy