Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis

Browse trials for

• Keratosis, Actinic 364
• Keratosis 348

Keywords

• actinic keratosis
• ablative fractional laser
• photodynamic therapy
• ablative density
• protoporphyrin IX

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Lead sponsor

Dong-A University is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Study arms

• Experimental
  5.5% density AFL-PDT

  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 laser density of 5.5%, 350 µm ablation depth, level 1 coagulation and a single pulse

  Drug: lidocaine/prilocaine (5%) application · Device: 2940-nm Er:YAG AFL pretreatment · Drug: MAL application · Other: Measurements of the fluorescence intensity · Device: irradiation with red light-emitting diode lamp

• Experimental
  11% density AFL-PDT

  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 laser density of 11%, 350 µm ablation depth, level 1 coagulation and a single pulse

  Drug: lidocaine/prilocaine (5%) application · Device: 2940-nm Er:YAG AFL pretreatment · Drug: MAL application · Other: Measurements of the fluorescence intensity · Device: irradiation with red light-emitting diode lamp

• Experimental
  22% density AFL-PDT

  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 laser density of 22%, 350 µm ablation depth, level 1 coagulation and a single pulse

  Drug: lidocaine/prilocaine (5%) application · Device: 2940-nm Er:YAG AFL pretreatment · Drug: MAL application · Other: Measurements of the fluorescence intensity · Device: irradiation with red light-emitting diode lamp

Interventions

• Druglidocaine/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

• Device2940-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 5.5% or 11% or 22% laser density with 350 µm ablation depth, level 1 coagulation and a single pulse

• DrugMAL 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

• OtherMeasurements 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.

• Deviceirradiation 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.

Primary outcomes

1. Differences of short-term complete response rates between 3 groups

   Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a noncomplete response (incomplete disappearance)

   Time frame: Short-term complete response rates were evaluated at 3 months after treatment

2. Differences of long-term complete response rates between 3 groups

   In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.

   Time frame: Long-term complete response rates were evaluated at 12 months

3. Difference of the recurrence rates between 3 groups

   In all cases of complete response, the patients were reviewed at 12 months to check for recurrence. Recurrence was assessed by inspection, dermoscopy, photography, palpation, and histologic findings. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.

   Time frame: Recurrence rates were evaluated respectively at 12 months after treatment

4. Differences of the fluorescence intensity between 3 groups

   After 3 hours of application with methyl aminolevulinate(MAL), Fluorescence imaging analysis was performed on treatment area 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 was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.

   Time frame: After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.

Secondary outcomes

1. Differences of cosmetic outcomes between 3 groups

   Cosmetic outcomes were graded as excellent (slight redness or pigmentation change), good (moderate redness or pigmentation change), fair (slight-to-moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)

   Time frame: The overall cosmetic outcome was assessed 12 months after treatment

2. Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups

   Adverse events reported by the patient were noted at each follow-up visit, including severity, duration and need for additional therapy. All events due to PDT were described as phototoxic reactions (i.e., erythema, post-inflammatory hyperpigmentation, oedema, itching, oozing, bleeding and so forth).

   Time frame: Within 12 months after each treatment

Individual participant data

Plan to share: No