Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis

PHASE4CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

February 1, 2017

Primary Completion Date

October 30, 2017

Study Completion Date

October 24, 2018

Conditions
Actinic Keratosis
Interventions
DRUG

lidocaine/prilocaine (5%) application

For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min

DEVICE

2940-nm Er:YAG AFL pretreatment

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 5.5% or 11% or 22% laser density with 350 µm ablation depth, level 1 coagulation and a single pulse

DRUG

MAL application

Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. Incubation time is 3 hours

OTHER

Measurements of the fluorescence intensity

After 3 hours of application with MAL, saline wash was performed and fluorescence imaging analysis was performed with ultraviolet examination light (model 31602,356 nm; Burton Medical Products Crop.) at 10 cm height above the base of each lesion. The red fluorescence (610 nm-700 nm) was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.

DEVICE

irradiation with red light-emitting diode lamp

After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.

Trial Locations (1)

49201

Dong-A University, Busan

All Listed Sponsors
lead

Dong-A University

OTHER

NCT03731988 - Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis | Biotech Hunter | Biotech Hunter