<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03012009</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2014/0735</org_study_id>
    <nct_id>NCT03012009</nct_id>
  </id_info>
  <brief_title>Laser Assisted Drug Delivery in the Treatment of Superficial Non Melanoma Skin Cancer: a Randomized Controlled Trial</brief_title>
  <official_title>A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Photodynamic therapy (PDT) is a well established treatment option for superficial non&#xD;
      melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD).&#xD;
      However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate&#xD;
      (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has&#xD;
      recently been studied in order to enhance the skin penetration of this photosensitizer. This&#xD;
      study compares the results of a full ablative and a fractional ablative CO2 laser mode as&#xD;
      pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain,&#xD;
      aesthetics and patient preference are investigated during twelve months of follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Superficial Basal Cell Carcinoma (sBCC) and Bowen Disease (BD) are malignant skin tumors&#xD;
      localised in the superficial epidermis. These tumors are highly prevalent in the caucasian&#xD;
      population. Diagnosis of sBCC and BD is often delayed because the clinical manifestation may&#xD;
      be discrete and lesions are sometimes wrongly diagnosed and treated as eczema. Once the&#xD;
      diagnosis is established, the lesions may cover an extensive area, making surgical excision&#xD;
      more difficult. At that moment, the physician can make use of less invasive techniques such&#xD;
      as photodynamic therapy (PDT). Pretreatment with an ablative carbon dioxide (CO2) laser has&#xD;
      recently been studied in order to enhance the skin penetration of the photosensitizer methyl&#xD;
      aminolevulinate (MAL). This study compares the results of a full ablative and a fractional&#xD;
      ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. Ablation of&#xD;
      the upper epiderm of the cancer results in an deeper penetration of MAL. Fractional ablation&#xD;
      is known to result in better wound healing compared to full ablative CO2 laser ablation,&#xD;
      because only small skin columns are ablated instead of the entire epidermal layer. Patients&#xD;
      with non operable sBCC or BD lesions covering an area of at least 5 cm2 or with the presence&#xD;
      of two small separated lesions, will be investigated. Lesions greater than 5 cm2 are divided&#xD;
      in two. After randomization, the half of the lesions will be pretreated with the full&#xD;
      ablative CO2 laser, while the other half with the fractional ablative CO2 laser. Afterwards,&#xD;
      the entire surface is treated with MAL-PDT. Such as in our current clinical practice, this&#xD;
      treatment modality is repeated after a two week interval. Thus, every subject undergoes both&#xD;
      treatment modalities, making within-patient comparison possible. The endpoints efficacy,&#xD;
      pain, aesthetics and patient preference are investigated during twelve months of follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical efficacy after twelve months of follow up</measure>
    <time_frame>month 12</time_frame>
    <description>A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy after six months of follow up</measure>
    <time_frame>month 6</time_frame>
    <description>A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy after three months of follow up</measure>
    <time_frame>month 3</time_frame>
    <description>A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological efficacy after twelve months of follow up</measure>
    <time_frame>month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during the first treatment session</measure>
    <time_frame>immediately after the first treatment session (day 1)</time_frame>
    <description>The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during the second treatment session</measure>
    <time_frame>immediately after the second treatment session (day 14)</time_frame>
    <description>The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after the first treatment session</measure>
    <time_frame>immediately after the first treatment session (day 1)</time_frame>
    <description>The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after one week of follow up, telephone survey</measure>
    <time_frame>day 7</time_frame>
    <description>The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects before the second treatment session</measure>
    <time_frame>before initiation of the second treatment session (day 14)</time_frame>
    <description>The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after the second treatment</measure>
    <time_frame>immediately after the second treatment session (day 14)</time_frame>
    <description>The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after two weeks of follow up, telephone survey</measure>
    <time_frame>day 21</time_frame>
    <description>The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after three months follow up</measure>
    <time_frame>month 3</time_frame>
    <description>The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after six months of follow up</measure>
    <time_frame>month 6</time_frame>
    <description>The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects after twelve months of follow up</measure>
    <time_frame>month 12</time_frame>
    <description>The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result after three months of follow up</measure>
    <time_frame>month 3</time_frame>
    <description>The aesthetic result is scored by a blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result after six months of follow up</measure>
    <time_frame>month 6</time_frame>
    <description>The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result after twelve months of follow up</measure>
    <time_frame>month 12</time_frame>
    <description>The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result according to the patient after three months of follow up</measure>
    <time_frame>month 3</time_frame>
    <description>The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result according to the patient after six months of follow up</measure>
    <time_frame>month 6</time_frame>
    <description>The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result according to the patient after twelve months of follow up</measure>
    <time_frame>month 12</time_frame>
    <description>The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technique of preference according to the patient</measure>
    <time_frame>month 12</time_frame>
    <description>Patients are asked for their preferred therapy. Following options exist: (1) full ablative CO2 laser + PDT, (2) fractional ablative CO2 laser + PDT, (3) no preference</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Bowen's Disease</condition>
  <condition>Superficial Basal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Full ablative CO2 laser + MAL PDT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment starts with a full ablative CO2 laser pretreatment under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with a LED lamp. This treatment is repeated after 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fractional ablative CO2 laser+ MAL PDT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment starts with a fractional ablative CO2 laser ablation under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with LED lamp. This treatment is repeated after 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>full ablative CO2 laser</intervention_name>
    <description>ablation to the level of de dermal papilla</description>
    <arm_group_label>Full ablative CO2 laser + MAL PDT</arm_group_label>
    <other_name>full ablative carbon dioxide laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>fractional ablative CO2 laser</intervention_name>
    <description>180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)</description>
    <arm_group_label>Fractional ablative CO2 laser+ MAL PDT</arm_group_label>
    <other_name>fractional ablative carbon dioxide laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MAL</intervention_name>
    <arm_group_label>Fractional ablative CO2 laser+ MAL PDT</arm_group_label>
    <arm_group_label>Full ablative CO2 laser + MAL PDT</arm_group_label>
    <other_name>methyl aminolevulinate</other_name>
    <other_name>Metvix® (Galderma)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LED lamp</intervention_name>
    <description>peak wavelength 630 nm, 37J/cm2</description>
    <arm_group_label>Fractional ablative CO2 laser+ MAL PDT</arm_group_label>
    <arm_group_label>Full ablative CO2 laser + MAL PDT</arm_group_label>
    <other_name>Aktilite® (Galderma)</other_name>
    <other_name>light-emitting diodes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine hydrochloride 2% with epinephrine</intervention_name>
    <arm_group_label>Fractional ablative CO2 laser+ MAL PDT</arm_group_label>
    <arm_group_label>Full ablative CO2 laser + MAL PDT</arm_group_label>
    <other_name>local anaesthetic</other_name>
    <other_name>xylocaine® 2% with epinephrine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: patients with the presence of&#xD;
&#xD;
          -  non operable superficial Basal Cell Carcinoma or Bowen's Disease lesions&#xD;
&#xD;
          -  and the presence of at least two lesions or the presence of one lesion covering an&#xD;
             area greater than 5cm2&#xD;
&#xD;
        Exclusion Criteria: pregnancy and/or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Boone, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ghent University, Dpt. of Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology, Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bowen's Disease</keyword>
  <keyword>Superficial Basal Cel Carcinoma</keyword>
  <keyword>Non melanoma skin cancer</keyword>
  <keyword>Photodynamic therapy</keyword>
  <keyword>PDT</keyword>
  <keyword>CO2 laser</keyword>
  <keyword>Laser assisted drug delivery</keyword>
  <keyword>Carbon dioxide laser</keyword>
  <keyword>Laser assisted photodynamic therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Basal Cell</mesh_term>
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Bowen's Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Methyl 5-aminolevulinate</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012009
org study id: EC/2014/0735
nct id: NCT03012009
lead sponsor: 
has dmc: No
Photodynamic therapy (PDT) is a well established treatment option for superficial non
      melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD).
      However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate
      (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has
      recently been studied in order to enhance the skin penetration of this photosensitizer. This
      study compares the results of a full ablative and a fractional ablative CO2 laser mode as
      pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain,
      aesthetics and patient preference are investigated during twelve months of follow up.
Superficial Basal Cell Carcinoma (sBCC) and Bowen Disease (BD) are malignant skin tumors
      localised in the superficial epidermis. These tumors are highly prevalent in the caucasian
      population. Diagnosis of sBCC and BD is often delayed because the clinical manifestation may
      be discrete and lesions are sometimes wrongly diagnosed and treated as eczema. Once the
      diagnosis is established, the lesions may cover an extensive area, making surgical excision
      more difficult. At that moment, the physician can make use of less invasive techniques such
      as photodynamic therapy (PDT). Pretreatment with an ablative carbon dioxide (CO2) laser has
      recently been studied in order to enhance the skin penetration of the photosensitizer methyl
      aminolevulinate (MAL). This study compares the results of a full ablative and a fractional
      ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. Ablation of
      the upper epiderm of the cancer results in an deeper penetration of MAL. Fractional ablation
      is known to result in better wound healing compared to full ablative CO2 laser ablation,
      because only small skin columns are ablated instead of the entire epidermal layer. Patients
      with non operable sBCC or BD lesions covering an area of at least 5 cm2 or with the presence
      of two small separated lesions, will be investigated. Lesions greater than 5 cm2 are divided
      in two. After randomization, the half of the lesions will be pretreated with the full
      ablative CO2 laser, while the other half with the fractional ablative CO2 laser. Afterwards,
      the entire surface is treated with MAL-PDT. Such as in our current clinical practice, this
      treatment modality is repeated after a two week interval. Thus, every subject undergoes both
      treatment modalities, making within-patient comparison possible. The endpoints efficacy,
      pain, aesthetics and patient preference are investigated during twelve months of follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical efficacy after twelve months of follow up
time frame: month 12
description: A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.
measure: Clinical efficacy after six months of follow up
time frame: month 6
description: A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.
measure: Clinical efficacy after three months of follow up
time frame: month 3
description: A three point scale with complete regression (CR), partial regression (PR) and no regression (NR) defined respectively as 100%, 25-99% and 0-25% regression.
measure: Histological efficacy after twelve months of follow up
time frame: month 12
measure: Pain during the first treatment session
time frame: immediately after the first treatment session (day 1)
description: The experienced pain during the treatment is scored bye the patient using a VAS scale of 100 mm.
measure: Pain during the second treatment session
time frame: immediately after the second treatment session (day 14)
description: The experienced pain during the treatment is scored by the patient using a VAS scale of 100 mm.
measure: Side effects after the first treatment session
time frame: immediately after the first treatment session (day 1)
description: The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects after one week of follow up, telephone survey
time frame: day 7
description: The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects before the second treatment session
time frame: before initiation of the second treatment session (day 14)
description: The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects after the second treatment
time frame: immediately after the second treatment session (day 14)
description: The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects after two weeks of follow up, telephone survey
time frame: day 21
description: The presence of following side effects is evaluated by the patient: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects after three months follow up
time frame: month 3
description: The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects after six months of follow up
time frame: month 6
description: The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Side effects after twelve months of follow up
time frame: month 12
description: The presence of following side effects is evaluated by the investigator: erythema, vesicles, pigment changes, scarring, infection and pain.
measure: Aesthetic result after three months of follow up
time frame: month 3
description: The aesthetic result is scored by a blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).
measure: Aesthetic result after six months of follow up
time frame: month 6
description: The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).
measure: Aesthetic result after twelve months of follow up
time frame: month 12
description: The aesthetic result is scored a by blinded investigator using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).
measure: Aesthetic result according to the patient after three months of follow up
time frame: month 3
description: The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).
measure: Aesthetic result according to the patient after six months of follow up
time frame: month 6
description: The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).
measure: Aesthetic result according to the patient after twelve months of follow up
time frame: month 12
description: The aesthetic result is scored by the patient using a four point scale: excellent (no significant changes), good (minor changes), poor (serious dyspigmentation, visible scarring), very poor (important scarring).
measure: Technique of preference according to the patient
time frame: month 12
description: Patients are asked for their preferred therapy. Following options exist: (1) full ablative CO2 laser + PDT, (2) fractional ablative CO2 laser + PDT, (3) no preference
arm group label: Full ablative CO2 laser + MAL PDT
arm group type: Active Comparator
description: The treatment starts with a full ablative CO2 laser pretreatment under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with a LED lamp. This treatment is repeated after 14 days.
arm group label: Fractional ablative CO2 laser+ MAL PDT
arm group type: Active Comparator
description: The treatment starts with a fractional ablative CO2 laser ablation under local anaesthesia with injectable lidocaine hydrochloride 2% with epinephrine. This ablation is followed by photodynamic therapy: MAL is topically applied, followed by a 3 hours incubation under occlusion, whereafter 10 minutes of illumination with LED lamp. This treatment is repeated after 14 days.
intervention type: Device
intervention name: full ablative CO2 laser
description: ablation to the level of de dermal papilla
arm group label: Full ablative CO2 laser + MAL PDT
other name: full ablative carbon dioxide laser
intervention type: Device
intervention name: fractional ablative CO2 laser
description: 180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)
arm group label: Fractional ablative CO2 laser+ MAL PDT
other name: fractional ablative carbon dioxide laser
intervention type: Drug
intervention name: MAL
arm group label: Fractional ablative CO2 laser+ MAL PDT
arm group label: Full ablative CO2 laser + MAL PDT
other name: methyl aminolevulinate
other name: Metvix® (Galderma)
intervention type: Device
intervention name: LED lamp
description: peak wavelength 630 nm, 37J/cm2
arm group label: Fractional ablative CO2 laser+ MAL PDT
arm group label: Full ablative CO2 laser + MAL PDT
other name: Aktilite® (Galderma)
other name: light-emitting diodes
intervention type: Drug
intervention name: lidocaine hydrochloride 2% with epinephrine
arm group label: Fractional ablative CO2 laser+ MAL PDT
arm group label: Full ablative CO2 laser + MAL PDT
other name: local anaesthetic
other name: xylocaine® 2% with epinephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Boone, MD PhD
role: Principal Investigator
affiliation: Ghent University, Dpt. of Dermatology
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Carcinoma, Basal Cell
mesh term: Skin Neoplasms
mesh term: Bowen's Disease
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Anesthetics, Local
mesh term: Anesthetics
mesh term: Methyl 5-aminolevulinate
mesh term: Epinephryl borate
sharing ipd: Undecided