Back to resultsEfficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lidocaine/prilocaine (5%) application
2940-nm Er:YAG AFL pretreatment
MAL application
Measurements of the fluorescence intensity
irradiation with red light-emitting diode lamp
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring actinic keratosis, ablative fractional laser, photodynamic therapy, ablative density, protoporphyrin IX
Eligibility Criteria
Inclusion Criteria:
- Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
Exclusion Criteria:
- 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
Sites / Locations
- Dong-A University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
5.5% density AFL-PDT
11% density AFL-PDT
22% density AFL-PDT
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
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)
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.
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.
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.
Secondary Outcome Measures
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)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03731988
Brief Title
Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
Official Title
A Comparison of the Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Density of Ablative Laser Channel in the Treatment of Actinic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
October 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
actinic keratosis, ablative fractional laser, photodynamic therapy, ablative density, protoporphyrin IX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5.5% density AFL-PDT
Arm Type
Experimental
Arm Description
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
Arm Title
11% density AFL-PDT
Arm Type
Experimental
Arm Description
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
Arm Title
22% density AFL-PDT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
lidocaine/prilocaine (5%) application
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
2940-nm Er:YAG AFL pretreatment
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
MAL application
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Measurements of the fluorescence intensity
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
irradiation with red light-emitting diode lamp
Intervention Description
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 Outcome Measure Information:
Title
Differences of short-term complete response rates between 3 groups
Description
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
Title
Differences of long-term complete response rates between 3 groups
Description
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
Title
Difference of the recurrence rates between 3 groups
Description
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
Title
Differences of the fluorescence intensity between 3 groups
Description
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 Outcome Measure Information:
Title
Differences of cosmetic outcomes between 3 groups
Description
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
Title
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-hoon Song, MD
Organizational Affiliation
Department of Dermatology, College of Medicine, Dong-A University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A University
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
49201
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
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