NCT03320447

Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease

Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dong-A University · Academic / Other
• Sex: All
• Age: 42 Years – 89 Years
• Healthy volunteers: Accepted

Summary

Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.

Detailed description

To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.

Conditions

• Bowen's Disease

Interventions

Type	Name	Description
DRUG	lidocaine-prilocaine 5% cream application	The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion
DEVICE	2940-nm Er:YAG AFL pretreatment	After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse
DRUG	methyl-aminolevulinate application	Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.
DEVICE	Illuminating using red light-emitting diode lamps	Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.

Timeline

• Start date: 2011-10-30
• Primary completion: 2016-10-30
• Completion: 2017-10-19
• First posted: 2017-10-25
• Last updated: 2017-10-25