Bowen's DiseasePhase 1NCT03320447
Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease
A Phase 1 study testing lidocaine-prilocaine 5% cream application, 2940-nm Er:YAG AFL pretreatment and methyl-aminolevulinate application in people with Bowen's Disease, run by Dong-A University.
Trial summary
Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). Read more about this study
- Who is it for?
- Ages 42 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowen's Disease
- What is being tested?
- lidocaine-prilocaine 5% cream application, 2940-nm Er:YAG AFL pretreatment and methyl-aminolevulinate application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2011to 19 Oct 2017
- Phase
- Phase 1
- 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 42 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- •Patients aged 18 years or more who diagnosed as bowen's disease
Who cannot join
- pregnancy or lactation
- active systemic infectious disease
- other inflammatory, infectious, or neoplastic skin diseases in the treated area
- allergy to MAL,other topical photosensitizers, or excipients of the cream
- history of photosensitivity
- use of immunosuppressive or photosensitizing drugs
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- participation in any other investigational study in the preceding 30 days
- history or indicators of poor compliance
- Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria
About this study
Official title: Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up
Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.
Read the detailed description
To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.
- Conditions
- Bowen's Disease
- Being tested
- lidocaine-prilocaine 5% cream application, 2940-nm Er:YAG AFL pretreatment, methyl-aminolevulinate application, Illuminating using red light-emitting diode lamps
- Keywords
- ablative fractional laser, photodynamic therapy, protoporphyrin IX, methy-aminolevulinate
- Medical subject headings
- Bowen's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine-prilocaine 5% cream applicationDrug
The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion
2940-nm Er:YAG AFL pretreatmentDevice
After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse
methyl-aminolevulinate applicationDrug
Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.
Illuminating using red light-emitting diode lampsDevice
Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
| Study group | Role | What they receive |
|---|---|---|
| MAL-PDT | Experimental | Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT Receives: Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps |
| AFL-PDT | Experimental | Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT Receives: Drug: lidocaine-prilocaine 5% cream application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Measured: Short-term CR rate was evaluated at 3 months
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Measured: Long-term CR rate was evaluated at 60 months
Difference of long-term recurrence rate between AFL-PDT and MAL-PDT at 60 months
In all cases of complete response, the patients were reviewed at 60 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
Measured: Recurrent rate was evaluated at 60 months
Secondary outcomes (1)
Difference of the cosmetic outcome between AFL-PDT and MAL-PDT
The overall cosmetic outcome was assessed by each investigator for all lesions that achieved complete response at 60 months, and was graded using a 4-point scale: excellent (only slight occurrence of redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight to moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)
Measured: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start30 Oct 2011
- Primary completion30 Oct 2016
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowen's DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320447
- Sponsor's protocol ID
- DAUderma-09
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 25 Oct 2017
- 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 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up
- ClinicalTrials.gov ID
- NCT03320447
- Acronym / sponsor ID
- DAUderma-09
- Conditions
- Bowen's Disease
- Keywords
- ablative fractional laser, photodynamic therapy, protoporphyrin IX, methy-aminolevulinate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 30 Oct 2011 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 25 Oct 2017 (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.
Er:YAG ablative fractional laser-assisted methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.
Detailed description
To compare the long-term efficacy and recurrence rates of AFL-PDT and standard MAL-PDT for the treatment of lower extremity BD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAL-PDT | Experimental | Drug: methyl-aminolevulinate application, Device: Illuminating using red light-emitting diode lampsPatients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT |
| AFL-PDT | Experimental | Drug: lidocaine-prilocaine 5% cream application, Device: 2940-nm Er:YAG AFL pretreatment, Drug: methyl-aminolevulinate application, Device: Illuminating using red light-emitting diode lampsPatients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT |
Who may qualify
- Ages
- 42 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Patients aged 18 years or more who diagnosed as bowen's disease
Key exclusion criteria (9 listed)
- pregnancy or lactation
- active systemic infectious disease
- other inflammatory, infectious, or neoplastic skin diseases in the treated area
- allergy to MAL,other topical photosensitizers, or excipients of the cream
- history of photosensitivity
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% cream applicationThe lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion | Drug | AFL-PDT |
| 2940-nm Er:YAG AFL pretreatmentAfter the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse | Device | AFL-PDT |
| methyl-aminolevulinate applicationImmediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. | Drug | AFL-PDT, MAL-PDT |
| Illuminating using red light-emitting diode lampsEach treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale. | Device | AFL-PDT, MAL-PDT |
Primary outcome
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
Time frame: Short-term CR rate was evaluated at 3 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
Time frame: Long-term CR rate was evaluated at 60 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Difference of long-term recurrence rate between AFL-PDT and MAL-PDT at 60 months
Time frame: Recurrent rate was evaluated at 60 months
In all cases of complete response, the patients were reviewed at 60 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
1 secondary outcome
Difference of the cosmetic outcome between AFL-PDT and MAL-PDT
Time frame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 60 months
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 25 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Bowen's Disease
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Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lidocaine-prilocaine 5% cream application, 2940-nm Er:YAG AFL pretreatment and methyl-aminolevulinate application in people with Bowen's Disease, run by Dong-A University.
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 9 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 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT (time frame: Short-term CR rate was evaluated at 3 months). The study lists 3 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 25 Oct 2017.