Actinic KeratosisPhase 4NCT03731988
Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy According to the Laser Density for Actinic Keratosis
A Phase 4 study testing lidocaine/prilocaine (5%) application, 2940-nm Er:YAG AFL pretreatment and MAL application in people with Actinic Keratosis, run by Dong-A University at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- lidocaine/prilocaine (5%) application, 2940-nm Er:YAG AFL pretreatment and MAL application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2017to 24 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Actinic Keratosis
- Being tested
- lidocaine/prilocaine (5%) application, 2940-nm Er:YAG AFL pretreatment, MAL application, Measurements of the fluorescence intensity, irradiation with red light-emitting diode lamp
- Keywords
- actinic keratosis, ablative fractional laser, photodynamic therapy, ablative density, protoporphyrin IX
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine/prilocaine (5%) applicationDrug
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
2940-nm Er:YAG AFL pretreatmentDevice
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
MAL applicationDrug
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
Measurements of the fluorescence intensityOther
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.
irradiation with red light-emitting diode lampDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 5.5% density AFL-PDT | Experimental | 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 Receives: 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 |
| 11% density AFL-PDT | Experimental | 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 Receives: 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 |
| 22% density AFL-PDT | Experimental | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Short-term complete response rates were evaluated at 3 months after treatment
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.
Measured: Long-term complete response rates were evaluated at 12 months
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.
Measured: Recurrence rates were evaluated respectively at 12 months after treatment
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.
Measured: After 3 hours of application with MAL, fluorescence intensity imaging was assessed 10 minutes before illumination.
Secondary outcomes (2)
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)
Measured: 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
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).
Measured: Within 12 months after each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Feb 2017
- Primary completion30 Oct 2017
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Ki-Hoon, Dong-A University
- Investigators
- Ki-hoon Song, MD, Principal investigator, Department of Dermatology, College of Medicine, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731988
- Sponsor's protocol ID
- DAUderma-10
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03731988
- Acronym / sponsor ID
- DAUderma-10
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, ablative fractional laser, photodynamic therapy, ablative density, protoporphyrin IX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5.5% density AFL-PDT | Experimental | 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 lampAfter 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 | Experimental | 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 lampAfter 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 | Experimental | 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 lampAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine/prilocaine (5%) applicationFor 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 | Drug | 11% density AFL-PDT, 22% density AFL-PDT, 5.5% density AFL-PDT |
| 2940-nm Er:YAG AFL pretreatmentAfter 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 | Device | 11% density AFL-PDT, 22% density AFL-PDT, 5.5% density AFL-PDT |
| MAL applicationImmediately 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 | Drug | 11% density AFL-PDT, 22% density AFL-PDT, 5.5% density AFL-PDT |
| Measurements of the fluorescence intensityAfter 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. | Other | 11% density AFL-PDT, 22% density AFL-PDT, 5.5% density AFL-PDT |
| irradiation with red light-emitting diode lampAfter 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. | Device | 11% density AFL-PDT, 22% density AFL-PDT, 5.5% density AFL-PDT |
Primary outcome
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)
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.
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.
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.
2 secondary outcomes
Differences of cosmetic outcomes between 3 groups
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-hoon Song, MD principal investigator
Department of Dermatology, College of Medicine, Dong-A University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine/prilocaine (5%) application, 2940-nm Er:YAG AFL pretreatment and MAL application in people with Actinic Keratosis, run by Dong-A University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences of short-term complete response rates between 3 groups (time frame: Short-term complete response rates were evaluated at 3 months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.