- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03731988
Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
November 4, 2018 updated by: Song Ki-Hoon, Dong-A University
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seo-gu
-
Busan, Seo-gu, Korea, Republic of, 49201
- Dong-A University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
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
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.
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
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.
|
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
|
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
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
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.
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
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.
|
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
|
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
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
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.
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences of short-term complete response rates between 3 groups
Time Frame: 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)
|
Short-term complete response rates were evaluated at 3 months after treatment
|
Differences of long-term complete response rates between 3 groups
Time Frame: 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.
|
Long-term complete response rates were evaluated at 12 months
|
Difference of the recurrence rates between 3 groups
Time Frame: 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.
|
Recurrence rates were evaluated respectively at 12 months after treatment
|
Differences of the fluorescence intensity between 3 groups
Time Frame: 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.
|
After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences of cosmetic outcomes between 3 groups
Time Frame: 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)
|
The overall cosmetic outcome was assessed 12 months after treatment
|
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between 3 groups
Time Frame: 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).
|
Within 12 months after each treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ki-hoon Song, MD, Department of Dermatology, College of Medicine, Dong-A University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
October 30, 2017
Study Completion (Actual)
October 24, 2018
Study Registration Dates
First Submitted
November 4, 2018
First Submitted That Met QC Criteria
November 4, 2018
First Posted (Actual)
November 6, 2018
Study Record Updates
Last Update Posted (Actual)
November 6, 2018
Last Update Submitted That Met QC Criteria
November 4, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Precancerous Conditions
- Keratosis, Actinic
- Keratosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anesthetics, Combined
- Lidocaine
- Prilocaine
- Lidocaine, Prilocaine Drug Combination
Other Study ID Numbers
- DAUderma-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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