Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
- Conditions
- Actinic Keratosis
- Interventions
- Drug: lidocaine/prilocaine (5%) applicationDrug: MAL applicationOther: Measurements of the fluorescence intensityDevice: irradiation with red light-emitting diode lamp
- Registration Number
- NCT03731988
- Lead Sponsor
- Dong-A University
- Brief Summary
Erbium:yttrium aluminum garnet (Er:YAG) ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional laser ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The formed MAZ depends on the laser parameters such as laser depth, laser density and laser passes, which affect the treatment outcome.
- Detailed Description
This study evaluated whether different laser densities influenced the efficacy, side effects, cosmetic outcomes, and protoporphyrin IX (PPIX) accumulation of AFL-PDT for facial AK in a randomized clinical trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
- photosensitivity disorder patients
- Lactating or pregnant women
- Patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
- Patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5.5% density AFL-PDT lidocaine/prilocaine (5%) application 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 5.5% density AFL-PDT MAL application 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 5.5% density AFL-PDT Measurements of the fluorescence intensity 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 5.5% density AFL-PDT irradiation with red light-emitting diode lamp 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 11% density AFL-PDT lidocaine/prilocaine (5%) application 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 11% density AFL-PDT MAL application 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 11% density AFL-PDT Measurements of the fluorescence intensity 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 11% density AFL-PDT irradiation with red light-emitting diode lamp 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 22% density AFL-PDT lidocaine/prilocaine (5%) application 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 22% density AFL-PDT MAL application 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 22% density AFL-PDT Measurements of the fluorescence intensity 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 22% density AFL-PDT irradiation with red light-emitting diode lamp 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
- Primary Outcome Measures
Name Time Method Differences of short-term complete response rates between 3 groups Short-term complete response rates were evaluated at 3 months after treatment Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a noncomplete response (incomplete disappearance)
Differences of long-term complete response rates between 3 groups Long-term complete response rates were evaluated at 12 months 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.
Difference of the recurrence rates between 3 groups Recurrence rates were evaluated respectively at 12 months after treatment 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.
Differences of the fluorescence intensity between 3 groups After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination. 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.
- Secondary Outcome Measures
Name Time Method Differences of cosmetic outcomes between 3 groups The overall cosmetic outcome was assessed 12 months after treatment 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)
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups Within 12 months after each treatment 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).
Trial Locations
- Locations (1)
Dong-A University
🇰🇷Busan, Seo-gu, Korea, Republic of