Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Microinvasive Squamous Cell Carcinoma
Interventions
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.

Trial Locations (1)

602-715

Dong-A University, Busan

All Listed Sponsors
lead

Dong-A University

OTHER

NCT02666534 - Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter