Efficacy of AFL-assisted PDT With Short Incubation Time in Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 1

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
    

Detailed description: 
      Photodynamic therapy (PDT) is widely used in the treatment of superficial skin cancer. It has
      an excellent cosmetic outcome, and it could be considered the first-line therapy for Actinic
      keratosis (AK). In PDT incubation time is required so that the photosensitizer can be
      converted to PpIX. The recommended treatment regimen of PDT requires a relatively long
      incubation time with ALA (4 hours) and MAL (3 hours) before illumination. Theoretically,
      ablative fractional laser (AFL) pre-treatment may facilitate the penetration and distribution
      of topically applied drugs, since the ablated laser holes extend into the dermis, thereby
      possibly acting as channels for drug uptake. However, knowledge on the optimal
      photosensitizer incubation time for AFL-PDT is limited. The objectives of this study were to
      compare the efficacy, recurrence rate, cosmetic outcome, and safety between AFL-PDT with 2
      and 3hours of incubation vs. conventional MAL-PDT in patients with facial and scalp AK.
    

Intervention name(s): 2h-AFL-PDT; 3h-AFL-PDT; 3hr-MAL-PDT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 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; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ablative fractional laser; Actinic keratosis; Efficacy; Photodynamic therapy; Short incubation time