Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
NCT03076918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2026-04-21
Summary
This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.
Conditions
- Keratosis, Actinic
Interventions
- DEVICE
-
FLEXITHERALIGHT PDT
Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours
- DEVICE
-
Aktilite® Galderma
Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes
Sponsors & Collaborators
-
National Research Agency, France
collaborator OTHER -
Institut National de la Santé Et de la Recherche Médicale, France
collaborator OTHER_GOV -
University Hospital, Lille
lead OTHER
Principal Investigators
-
Laurent Mortier, MD, PhD · University Hospital, Lille
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- France
Study Locations
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