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).
Aktilite CL 128 lamp
actinic keratosis
light-emitting fabric
photodynamic therapy
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
26 Apr 2019
26 Apr 2019
Historique:
received:
29
11
2018
accepted:
07
02
2019
revised:
04
02
2019
entrez:
27
4
2019
pubmed:
27
4
2019
medline:
27
4
2019
Statut:
epublish
Résumé
Actinic keratosis (AK) is a common early in situ skin carcinoma caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. To prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery, and photodynamic therapy (PDT). The aim of this study is to assess the noninferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device (PDT using the Phosistos protocol [P-PDT]) compared with the conventional protocol (PDT using the conventional protocol [C-PDT]) in the treatment of AK. In this randomized, controlled, multicenter, intra-individual, phase II noninferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing, and statistical results will be available in the first half of 2019. In case of noninferiority in efficacy and superiority in tolerability of P-PDT compared with C-PDT, P-PDT could become the treatment of choice for AK. ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek). DERR1-10.2196/12990.
Sections du résumé
BACKGROUND
BACKGROUND
Actinic keratosis (AK) is a common early in situ skin carcinoma caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. To prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery, and photodynamic therapy (PDT).
OBJECTIVE
OBJECTIVE
The aim of this study is to assess the noninferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device (PDT using the Phosistos protocol [P-PDT]) compared with the conventional protocol (PDT using the conventional protocol [C-PDT]) in the treatment of AK.
METHODS
METHODS
In this randomized, controlled, multicenter, intra-individual, phase II noninferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm
RESULTS
RESULTS
Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing, and statistical results will be available in the first half of 2019.
CONCLUSIONS
CONCLUSIONS
In case of noninferiority in efficacy and superiority in tolerability of P-PDT compared with C-PDT, P-PDT could become the treatment of choice for AK.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/12990.
Identifiants
pubmed: 31025953
pii: v8i4e12990
doi: 10.2196/12990
pmc: PMC6658310
doi:
Banques de données
ClinicalTrials.gov
['NCT03076892']
Types de publication
Journal Article
Langues
eng
Pagination
e12990Informations de copyright
©Anne-Sophie Vignion-Dewalle, Henry Abi Rached, Elise Thecua, Fabienne Lecomte, Pascal Deleporte, Hélène Béhal, Theresa Hommel, Alain Duhamel, Rolf-Markus Szeimies, Laurent Mortier, Serge Mordon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.04.2019.
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