EUCTR2015-002537-22-AT
Active, not recruiting
Phase 1
Photodynamic therapy for skin rejuvenation: A pilotstudy evaluating theeffectiveness of 5-aminolevulinic acid -based photodynamic therapy in thetreatment of photodamaged skin - PDT with LED in treatment of photodamage
Medizinische Universität Wien, Univ. Klinik f. Dermatologie0 sites13 target enrollmentStarted: December 23, 2016Last updated:
ConditionsPhotodamaged skinMedDRA version: 19.1Level: PTClassification code 10068388Term: Actinic elastosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 19.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsAmeluz
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Medizinische Universität Wien, Univ. Klinik f. Dermatologie
- Enrollment
- 13
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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