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

Phase 1

• Conditions: Actinic keratoses (AK) as precursors of squamous cell carcinoma (SCC) of the skin; MedDRA version: 19.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002245-66-AT
• Lead Sponsor: Medizinische Universität Wien, Univ. Klinik f. Dermatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-30
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <2,5 cm
Skin type I-IV
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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified