NCT03325803

Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Dong-A University · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Er:YAG ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional laser ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The formed MAZ depends on the laser parameters such as laser depth, laser density and laser passes, which affect the treatment outcome.

Detailed description

The investigators aimed to investigate whether the use of increased laser ablative depth affects the efficacy, side effects, cosmetic outcomes, and PPIX accumulation of AFL-PDT for facial AK in a randomized clinical trial.

Conditions

• Actinic Dermatosis

Interventions

Type	Name	Description
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 150 µm ablation depth, level 1 coagulation, 22% treatment density 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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-30
• Completion: 2017-09-20
• First posted: 2017-10-30
• Last updated: 2017-10-31

Locations

1 site across 1 country: South Korea