scholarly journals 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)

10.2196/12990 ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. e12990 ◽  
Author(s):  
Anne-Sophie Vignion-Dewalle ◽  
Henry Abi Rached ◽  
Elise Thecua ◽  
Fabienne Lecomte ◽  
Pascal Deleporte ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Phase Ii ◽  
Actinic Keratosis ◽  
Light Emitting ◽  
Randomized Controlled ◽  
Individual Phase

scholarly journals 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) (Preprint)

2018 ◽  
Author(s):  
Anne-Sophie Vignion-Dewalle ◽  
Henry Abi Rached ◽  
Elise Thecua ◽  
Fabienne Lecomte ◽  
Pascal Deleporte ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Phase Ii ◽  
Actinic Keratosis ◽  
Response Rate ◽  
Complete Response Rate ◽  
Red Light ◽  
Complete Response ◽  
Light Emitting ◽  
Randomized Controlled ◽  
Individual Phase

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 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 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/cm2) for 2.5 hours so that a light dose of 12 J/cm2 is achieved. In the control area (C-PDT area), a 37 J/cm2 red light irradiation is performed 3 hours after MAL application. Recurrent AK at 3 months is retreated. The primary end point is the lesion complete response rate at 3 months. Secondary end points include pain scores at 1 day, local tolerance at 7 days, lesion complete response rate at 6 months, cosmetic outcome at 3 and 6 months, and patient-reported quality of life and satisfaction throughout the study. A total of 45 patients needs to be recruited. 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 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. CLINICALTRIAL ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12990

scholarly journals Application of photodynamic therapy with the use of superluminescent light-emitting diode (sLED) lamp in actinic keratosis

2019 ◽  
Vol 106 (4) ◽  
pp. 372-383
Author(s):  
Joanna Bartosińska ◽  
Agnieszka Gerkowicz ◽  
Marta Niewiedzioł ◽  
Paulina Szczepanik-Kułak ◽  
Mirosław Kwaśny ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Actinic Keratosis ◽  
Light Emitting Diode ◽  
Light Emitting
Sign in / Sign up

Export Citation Format

Share Document