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A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)
This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp
Details
| Lead sponsor | University Hospital, Lille |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 47 |
| Start date | 2016-09 |
| Completion | 2017-11 |
Conditions
- Keratosis, Actinic
Interventions
- Aktilite® Galderma
- PHOS ISTOS PDT
Primary outcomes
- Treated lesion response rate — up to Month 6
Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed
Countries
France, Germany