Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS (PHOS-ISTOS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03076892 |
Recruitment Status :
Completed
First Posted : March 10, 2017
Last Update Posted : November 14, 2017
|
Sponsor:
University Hospital, Lille
Collaborators:
European Commission
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | March 7, 2017 | |||
First Posted Date ICMJE | March 10, 2017 | |||
Last Update Posted Date | November 14, 2017 | |||
Actual Study Start Date ICMJE | September 2016 | |||
Actual Primary Completion Date | November 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Treated lesion response rate [ Time Frame: up to Month 6 ] Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS | |||
Official Title ICMJE | A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT) | |||
Brief Summary | 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 | |||
Detailed Description | The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then scheduled | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Split Face intra individual comparison Masking: None (Open Label)Primary Purpose: Treatment |
|||
Condition ICMJE | Keratosis, Actinic | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Béhal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
47 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2017 | |||
Actual Primary Completion Date | November 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT03076892 | |||
Other Study ID Numbers ICMJE | 2015_79 2016-A00010-51 ( Other Identifier: ID-RCB number, ANSM ) |
|||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
|
|||
Responsible Party | University Hospital, Lille | |||
Study Sponsor ICMJE | University Hospital, Lille | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | University Hospital, Lille | |||
Verification Date | November 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |