Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-02-09 @ 2:42 AM
Study NCT ID:
NCT03076918
Status:
TERMINATED
Last Update Posted:
2018-05-18
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
decision of the investigator in the face of new scientific knowledge
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Flexithera
Brief 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®.
Detailed Description:
The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47 patients. All participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with FLEXITHERALIGHT device followed by a continuous red light Spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of methyl aminolevulinate).
Patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be scheduled.
Patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be scheduled.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-A01096-39 | OTHER | ID-RCB number, ANSM | View |