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Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis

NCT02248298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2014-09-25

No results posted yet for this study

Summary

Photodynamic therapy (PDT) using methyl aminolevulinate (MAL) is an effective first-line treatment for actinic keratosis (AK). Erbium: yttrium-aluminium-garnet (Er:YAG) ablative fractional laser-assisted MAL-PDT (AFL-PDT) has shown significant benefit for the treatment of AK. However, knowledge on the optimal photosensitizer incubation time for AFL-PDT is limited

Conditions

  • Actinic Keratosis

Interventions

DRUG

2h-AFL-PDT

AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. In the 3h-MAL-PDT group, the above mentioned procedures were not performed. 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. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 2 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 total light dose of 37 J/cm-2

DRUG

3h-AFL-PDT

AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. In the 3h-MAL-PDT group, the above mentioned procedures were not performed. 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. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). 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 total light dose of 37 J/cm-2

DRUG

3hr-MAL-PDT

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. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). 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 total light dose of 37 J/cm-2.

Sponsors & Collaborators

  • Dong-A University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248298 on ClinicalTrials.gov