<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/NCT03025724</url>
  </required_header>
  <id_info>
    <org_study_id>897494</org_study_id>
    <nct_id>NCT03025724</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ</brief_title>
  <official_title>Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DUSA Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment&#xD;
      of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for&#xD;
      treating SCCis. This study will also secondarily evaluate the tolerability of using&#xD;
      photodynamic therapy for treatment of SCCis.&#xD;
&#xD;
      Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include&#xD;
      lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to&#xD;
      topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light&#xD;
      (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of &gt; 6 skin&#xD;
      cancers in the past year, photosensitizing condition such as lupus, or sensitivity to&#xD;
      porphyrins.&#xD;
&#xD;
      Age, gender, size, and location of the SCCis will be recorded. All subjects will receive&#xD;
      surgical treatment of their SCCis. The control group will undergo a surgical excision of the&#xD;
      tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The&#xD;
      intervention group will receive PDT plus surgical treatment. Photographs of the lesion will&#xD;
      be taken at each study visit. Subjects in the intervention group will then undergo the study&#xD;
      procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to&#xD;
      the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA&#xD;
      incubation and blue light exposure. At 6 months after the last treatment, subjects in the&#xD;
      intervention group will return for clinical follow-up and surgical excision of the lesion.&#xD;
      After excision, the specimen will be sent for processing by pathology and subjects will be&#xD;
      asked to fill out a satisfaction visual analog scale. All slides will be read by a&#xD;
      board-certified dermatopathologist. Side effects will also be monitored using the same graded&#xD;
      scale described previously. Mild adverse events that have been associated with PDT, including&#xD;
      erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation.&#xD;
      These reactions usually occur during or immediately after the PDT treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: This trial will evaluate the effectiveness of photodynamic therapy (aminolevulinic&#xD;
      acid plus blue light) for treatment of cutaneous squamous cell carcinoma in situ (SCCis).&#xD;
&#xD;
      This pilot study will prospectively recruit 40 subjects with biopsy proven SCCis at the time&#xD;
      of their visit at University Dermatology East Providence office. Exclusion criteria include&#xD;
      lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to&#xD;
      topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light&#xD;
      (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of &gt; 6 skin&#xD;
      cancers in the past year, photosensitizing condition such as lupus, or sensitivity to&#xD;
      porphyrins.&#xD;
&#xD;
      Half of the subjects will be randomized to the control group (n=20), and the remaining&#xD;
      subjects (n=20) will be randomized to the intervention group. The subject's age and gender,&#xD;
      and size and location of the SCCis will be recorded. For the control group, subjects will&#xD;
      undergo a surgical excision of the tumor, which is the gold standard of treatment for SCCis.&#xD;
      After the excision, subjects will be asked to fill out a satisfaction survey. They will not&#xD;
      receive any PDT treatment.&#xD;
&#xD;
      For the intervention group, photographs of the lesion will be taken at each study visit. A&#xD;
      clear transparency film will be used to trace the clinical margins of the lesion, as well as&#xD;
      any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo&#xD;
      the study procedure. The area to be treated will be swabbed with an alcohol wipe and allowed&#xD;
      to dry. The investigator will apply topical 20% 5-ALA to the SCCis. Then, the area will be&#xD;
      covered with Tegaderm film for 3 hours. At the end of 3 hours, the Tegaderm will be removed&#xD;
      and the subject will be exposed to a blue light source, which is the standard protocol for&#xD;
      treatment with blue light PDT. During administration of the light and immediately afterwards,&#xD;
      the subject will be monitored for any side effects, such as erythema, edema,&#xD;
      stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items&#xD;
      will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after&#xD;
      treatment. This process will be repeated at the next visit 3-5 weeks later. At six months&#xD;
      after the last treatment, subjects in the intervention group will return for clinical&#xD;
      follow-up and surgical excision of the lesion. Patients will complete a satisfaction survey&#xD;
      at the end of this visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the incidence of SCCis present after exposure to the experimental procedures</measure>
    <time_frame>six months</time_frame>
    <description>After the excision, investigators will collect patient satisfaction data. Investigators will also review the final pathology report for presence or absence of the tumor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician graded scoring on a 1 to 4 scale of erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation.</measure>
    <time_frame>six months</time_frame>
    <description>The subjects will be monitored for any side effects, such as erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). Lastly, they will be asked to fill out a satisfaction survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levulan Kerastick</intervention_name>
    <description>Intervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Intervention Group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>blue light source</intervention_name>
    <description>At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals).</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>participant satisfaction survey</intervention_name>
    <description>Participants will be asked to fill out a satisfaction survey.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18, any gender&#xD;
&#xD;
          2. Biopsy proven SCCis without evidence of microinvasion beyond the epidermis&#xD;
&#xD;
          3. Low-risk site (trunk, arms, legs)&#xD;
&#xD;
          4. Clinical presence of tumor at biopsy site to ensure that biopsy itself was not&#xD;
             curative&#xD;
&#xD;
          5. Lesion &lt;2cm&#xD;
&#xD;
          6. Subject amenable to surgical excision at 6 months after the last PDT treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. High-risk site (head, neck, hands, feet)&#xD;
&#xD;
          2. Previous severe adverse reaction to topical 20% aminolevulinic acid (Kerastick)&#xD;
&#xD;
          3. Previous severe adverse reaction to blue light (BLU-U)&#xD;
&#xD;
          4. Allergy to Tegaderm&#xD;
&#xD;
          5. Exclusion of any patient with primary or secondary immunosuppression&#xD;
&#xD;
          6. History of &gt; 6 skin cancers in the past year&#xD;
&#xD;
          7. Photosensitizing condition such as lupus&#xD;
&#xD;
          8. Sensitivity to porphyrins&#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>Kachiu C. Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Dermatology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Steven K. Knapp, BA</last_name>
    <phone>401-444-7853</phone>
    <email>sknapp@lifespan.org</email>
  </overall_contact>
  <reference>
    <citation>Green A. Changing patterns in incidence of non-melanoma skin cancer. Epithelial Cell Biol. 1992 Jan;1(1):47-51.</citation>
    <PMID>1307938</PMID>
  </reference>
  <reference>
    <citation>Glass AG, Hoover RN. The emerging epidemic of melanoma and squamous cell skin cancer. JAMA. 1989 Oct 20;262(15):2097-100.</citation>
    <PMID>2795783</PMID>
  </reference>
  <reference>
    <citation>Brancaleon L, Moseley H. Laser and non-laser light sources for photodynamic therapy. Lasers Med Sci. 2002;17(3):173-86. doi: 10.1007/s101030200027.</citation>
    <PMID>12181632</PMID>
  </reference>
  <reference>
    <citation>Kennedy JC, Pottier RH, Pross DC. Photodynamic therapy with endogenous protoporphyrin IX: basic principles and present clinical experience. J Photochem Photobiol B. 1990 Jun;6(1-2):143-8. doi: 10.1016/1011-1344(90)85083-9.</citation>
    <PMID>2121931</PMID>
  </reference>
  <reference>
    <citation>Tierney E, Barker A, Ahdout J, Hanke CW, Moy RL, Kouba DJ. Photodynamic therapy for the treatment of cutaneous neoplasia, inflammatory disorders, and photoaging. Dermatol Surg. 2009 May;35(5):725-46. doi: 10.1111/j.1524-4725.2009.01117.x. Epub 2009 Mar 20.</citation>
    <PMID>19309338</PMID>
  </reference>
  <results_reference>
    <citation>Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19.</citation>
    <PMID>20231499</PMID>
  </results_reference>
  <results_reference>
    <citation>Miller DL, Weinstock MA. Nonmelanoma skin cancer in the United States: incidence. J Am Acad Dermatol. 1994 May;30(5 Pt 1):774-8. doi: 10.1016/s0190-9622(08)81509-5.</citation>
    <PMID>8176018</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminolevulinic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03025724
org study id: 897494
nct id: NCT03025724
lead sponsor: 
collaborator: 
has dmc: Yes
This pilot study will evaluate the effectiveness of using photodynamic therapy for treatment
      of cutaneous squamous cell in situ (SCCis). Our hypothesis is that PDT will be effective for
      treating SCCis. This study will also secondarily evaluate the tolerability of using
      photodynamic therapy for treatment of SCCis.

      Investigators plan to enroll 40 subjects with biopsy proven SCCis. Exclusion criteria include
      lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to
      topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light
      (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin
      cancers in the past year, photosensitizing condition such as lupus, or sensitivity to
      porphyrins.

      Age, gender, size, and location of the SCCis will be recorded. All subjects will receive
      surgical treatment of their SCCis. The control group will undergo a surgical excision of the
      tumor. After the excision, subjects will be asked to fill out a satisfaction survey. The
      intervention group will receive PDT plus surgical treatment. Photographs of the lesion will
      be taken at each study visit. Subjects in the intervention group will then undergo the study
      procedure of application of topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to
      the SCCis. At 3-5 weeks after the initial treatment, the subject will repeat the 3-hour ALA
      incubation and blue light exposure. At 6 months after the last treatment, subjects in the
      intervention group will return for clinical follow-up and surgical excision of the lesion.
      After excision, the specimen will be sent for processing by pathology and subjects will be
      asked to fill out a satisfaction visual analog scale. All slides will be read by a
      board-certified dermatopathologist. Side effects will also be monitored using the same graded
      scale described previously. Mild adverse events that have been associated with PDT, including
      erythema, skin crusting, superficial blistering, hypopigmentation, and hyperpigmentation.
      These reactions usually occur during or immediately after the PDT treatment.
Objective: This trial will evaluate the effectiveness of photodynamic therapy (aminolevulinic
      acid plus blue light) for treatment of cutaneous squamous cell carcinoma in situ (SCCis).

      This pilot study will prospectively recruit 40 subjects with biopsy proven SCCis at the time
      of their visit at University Dermatology East Providence office. Exclusion criteria include
      lesion in high-risk site (head, neck, hands, feet), previous severe adverse reaction to
      topical 20% aminolevulinic acid (Kerastick), previous severe adverse reaction to blue light
      (BLU-U), allergy to Tegaderm, primary or secondary immunosuppression, history of > 6 skin
      cancers in the past year, photosensitizing condition such as lupus, or sensitivity to
      porphyrins.

      Half of the subjects will be randomized to the control group (n=20), and the remaining
      subjects (n=20) will be randomized to the intervention group. The subject's age and gender,
      and size and location of the SCCis will be recorded. For the control group, subjects will
      undergo a surgical excision of the tumor, which is the gold standard of treatment for SCCis.
      After the excision, subjects will be asked to fill out a satisfaction survey. They will not
      receive any PDT treatment.

      For the intervention group, photographs of the lesion will be taken at each study visit. A
      clear transparency film will be used to trace the clinical margins of the lesion, as well as
      any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo
      the study procedure. The area to be treated will be swabbed with an alcohol wipe and allowed
      to dry. The investigator will apply topical 20% 5-ALA to the SCCis. Then, the area will be
      covered with Tegaderm film for 3 hours. At the end of 3 hours, the Tegaderm will be removed
      and the subject will be exposed to a blue light source, which is the standard protocol for
      treatment with blue light PDT. During administration of the light and immediately afterwards,
      the subject will be monitored for any side effects, such as erythema, edema,
      stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items
      will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after
      treatment. This process will be repeated at the next visit 3-5 weeks later. At six months
      after the last treatment, subjects in the intervention group will return for clinical
      follow-up and surgical excision of the lesion. Patients will complete a satisfaction survey
      at the end of this visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the incidence of SCCis present after exposure to the experimental procedures
time frame: six months
description: After the excision, investigators will collect patient satisfaction data. Investigators will also review the final pathology report for presence or absence of the tumor.
measure: Physician graded scoring on a 1 to 4 scale of erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation.
time frame: six months
description: The subjects will be monitored for any side effects, such as erythema, edema, stinging/burning, blisters/crusting, hyperpigmentation, and hypopigmentation. These items will be graded on a scale of 1 to 4 (1=mild and 4=severe) assessed immediately after treatment.
arm group label: Control
arm group type: No Intervention
description: After the surgical excision, subjects will be asked to fill out a satisfaction survey. They will not receive any PDT treatment.
arm group label: Intervention Group
arm group type: Experimental
description: Subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours. At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals). Lastly, they will be asked to fill out a satisfaction survey.
intervention type: Drug
intervention name: Levulan Kerastick
description: Intervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours.
arm group label: Intervention Group
other name: Intervention Group
intervention type: Device
intervention name: blue light source
description: At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals).
arm group label: Intervention Group
intervention type: Other
intervention name: participant satisfaction survey
description: Participants will be asked to fill out a satisfaction survey.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kachiu C. Lee, MD
role: Principal Investigator
affiliation: University Dermatology
last name: Steven K. Knapp, BA
phone: 401-444-7853
email: sknapp@lifespan.org
citation: Green A. Changing patterns in incidence of non-melanoma skin cancer. Epithelial Cell Biol. 1992 Jan;1(1):47-51.
PMID: 1307938
citation: Glass AG, Hoover RN. The emerging epidemic of melanoma and squamous cell skin cancer. JAMA. 1989 Oct 20;262(15):2097-100.
PMID: 2795783
citation: Brancaleon L, Moseley H. Laser and non-laser light sources for photodynamic therapy. Lasers Med Sci. 2002;17(3):173-86. doi: 10.1007/s101030200027.
PMID: 12181632
citation: Kennedy JC, Pottier RH, Pross DC. Photodynamic therapy with endogenous protoporphyrin IX: basic principles and present clinical experience. J Photochem Photobiol B. 1990 Jun;6(1-2):143-8. doi: 10.1016/1011-1344(90)85083-9.
PMID: 2121931
citation: Tierney E, Barker A, Ahdout J, Hanke CW, Moy RL, Kouba DJ. Photodynamic therapy for the treatment of cutaneous neoplasia, inflammatory disorders, and photoaging. Dermatol Surg. 2009 May;35(5):725-46. doi: 10.1111/j.1524-4725.2009.01117.x. Epub 2009 Mar 20.
PMID: 19309338
citation: Rogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19.
PMID: 20231499
citation: Miller DL, Weinstock MA. Nonmelanoma skin cancer in the United States: incidence. J Am Acad Dermatol. 1994 May;30(5 Pt 1):774-8. doi: 10.1016/s0190-9622(08)81509-5.
PMID: 8176018
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Carcinoma in Situ
mesh term: Aminolevulinic Acid
sharing ipd: No