<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/NCT01689935</url>
  </required_header>
  <id_info>
    <org_study_id>2009-P-002352</org_study_id>
    <nct_id>NCT01689935</nct_id>
  </id_info>
  <brief_title>Reduced Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne (i-PDT)</brief_title>
  <acronym>i-PDT</acronym>
  <official_title>A Pilot Clinical Trial To Reduce Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study aims to compare different methods for helping difficult to treat or&#xD;
      scarring (cystic) acne, ALA-PDT and i-PDT.&#xD;
&#xD;
      There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been&#xD;
      reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses&#xD;
      a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.&#xD;
&#xD;
      Levulan® is applied directly to facial/back acne. This is the way that it is usually applied.&#xD;
      Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where&#xD;
      the Levulan® was applied is exposed to a red light for activation.&#xD;
&#xD;
      The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin&#xD;
      through the skin pores to where the glands are. PDT destroys the glands reducing the acne&#xD;
      lesion.&#xD;
&#xD;
      Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure&#xD;
      also has some side effects. Some of the side effects include pain, burning sensation during&#xD;
      the procedure, and redness, tenderness, and swelling after the procedure.&#xD;
&#xD;
      At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators&#xD;
      developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT&#xD;
      is aimed at reducing the side-effects of ALA- PDT.&#xD;
&#xD;
      The difference between these two procedures is that i-PDT uses a light source that will&#xD;
      prevent Levulan® accumulation in the normal skin surface. The investigators would like to&#xD;
      find out if Levulan® will be placed only inside the sebaceous glands.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects&#xD;
      will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the&#xD;
      right and left. One half of the face or back will receive ALA-PDT and the other half will&#xD;
      receive i-PDT. For subjects with back acne, red light and blue light alone will be applied&#xD;
      for comparison.&#xD;
&#xD;
      Healthy subjects with difficult to treat moderate or severe acne on the face or back are&#xD;
      eligible to enroll.&#xD;
&#xD;
      The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with&#xD;
      follow-ups 1, 3 and 6 months after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2009</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris</measure>
    <time_frame>0, 4, 8, 12, 16, 24 and 36 weeks</time_frame>
    <description>0. Clear: No lesions but erythema and residual hyperpigmentation may be present&#xD;
Almost Clear: few scattered comedones and a few (&lt; five) small papules&#xD;
Mild:&lt; 50% face involved, many comedones/papules and pustules&#xD;
Moderate:&gt; 50% of face involved. Numerous comedones, papules and pustules&#xD;
Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts.&#xD;
1) Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain reduction</measure>
    <time_frame>During, immediately after and 24 h after treatment</time_frame>
    <description>Visual Pain Scale - 0 (no pain) -10 (severe pain)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Side-effects Profile</measure>
    <time_frame>Immediately after treatment and during follow-up visits</time_frame>
    <description>Evaluation of overall side-effects of each test site</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No drug, no treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALA-PDT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>i-PDT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red Light only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Red light only - no drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blue light only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blue light only - no drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20 % Aminolevulinic Acid</intervention_name>
    <description>topical medication for ALA-PDT and i-PDT</description>
    <arm_group_label>ALA-PDT</arm_group_label>
    <arm_group_label>i-PDT</arm_group_label>
    <other_name>5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Red light only</intervention_name>
    <description>Red Light therapy</description>
    <arm_group_label>Red Light only</arm_group_label>
    <other_name>Omnilux Revive</other_name>
    <other_name>635 nm - LED (Phototherapeutics, Cheshire, UK)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blue light only</intervention_name>
    <description>Blue light only</description>
    <arm_group_label>Blue light only</arm_group_label>
    <arm_group_label>i-PDT</arm_group_label>
    <other_name>Omnilux Blue</other_name>
    <other_name>415 nm LED (Phototherapeutics, Cheshire, UK)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Subjects with ages between 14 and 50 years, male or female.&#xD;
&#xD;
          2. Subjects with severe acne lesions (one or more nodules or cysts present) on their&#xD;
             backs or face&#xD;
&#xD;
          3. Presence of moderate acne on the back and/or face that has been recalcitrant to&#xD;
             previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3&#xD;
             months) improvement after using:&#xD;
&#xD;
               -  Accutane® for at least one completed treatment cycle, and/or&#xD;
&#xD;
               -  Oral antibiotic for ≥ 3 months; and/or&#xD;
&#xD;
               -  Topical prescription retinoids (tretinoin - retinoic acid, adapalene, tazarotene&#xD;
                  or other derivatives) for ≥ 3 months, and/or&#xD;
&#xD;
               -  Topical benzoyl peroxide 2.5% or higher concentrations for ≥ 3 months&#xD;
&#xD;
               -  Hormonal treatments** for ≥ 3 months.&#xD;
&#xD;
          4. Willingness to participate in the study&#xD;
&#xD;
          5. Willingness to receive ALA-PDT treatment&#xD;
&#xD;
          6. Informed consent agreement signed by the subject&#xD;
&#xD;
          7. Willingness to follow the treatment schedule and post treatment care requirements&#xD;
&#xD;
          8. Willingness to not use topical or systemic (oral) anti-acne medications including&#xD;
             medicated shampoo or soap during the study period.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Subjects receiving concurrent oral retinoids or antibiotics&#xD;
&#xD;
             ** Subjects with chronic use of antibiotics may be included if proven that its use has&#xD;
             not changed the severity of their acne. AND&#xD;
&#xD;
             *** Chronic use of antibiotic is considered ≥ 2 years of continuous use.&#xD;
&#xD;
          2. Scarring or infection of the area to be treated&#xD;
&#xD;
          3. Known photosensitivity&#xD;
&#xD;
          4. Presence of suntan in the area to be treated&#xD;
&#xD;
          5. Subjects who have taken medication known to induce photosensitivity in the previous 3&#xD;
             months&#xD;
&#xD;
          6. Subjects who have had prior oral retinoid (Accutane®) use within 6 months of entering&#xD;
             the study&#xD;
&#xD;
          7. Prior oral antibiotic use within 1 month of entering the study (see exclusion #1)&#xD;
&#xD;
          8. Topical antibiotic or other topical anti-acne treatments use within 2 weeks of&#xD;
             entering the study&#xD;
&#xD;
          9. Known anticoagulation or thromboembolic condition&#xD;
&#xD;
         10. Subjects who are immunosuppressed&#xD;
&#xD;
         11. Subject is unable to comply with treatment, home care or follow-up visits&#xD;
&#xD;
         12. Subject is pregnant or breast feeding&#xD;
&#xD;
         13. Subject has a history of being on photosensitive medications (thiazides [used to treat&#xD;
             high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides&#xD;
             [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel&#xD;
             blockers [used to treat hypertension]. phenothiazines [used to treat serious emotional&#xD;
             problems]).&#xD;
&#xD;
         14. Known skin sensitivity to blue light&#xD;
&#xD;
         15. Porphyria (a disorder of the metabolism that can lead to sensitivity to light)&#xD;
&#xD;
         16. Allergies to chemicals called porphyrins&#xD;
&#xD;
         17. Subjects who started hormonal treatment (for medical conditions or birth control)&#xD;
             within less than 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Rox Anderson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernanda H Sakamoto, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 5, 2011</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Richard Rox Anderson, MD</investigator_full_name>
    <investigator_title>Professor, Harvard Medical School (Dermatology)</investigator_title>
  </responsible_party>
  <keyword>Acne vulgaris</keyword>
  <keyword>Photodynamic Therapy</keyword>
  <keyword>Side-effects</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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>
  <!-- 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/NCT01689935
org study id: 2009-P-002352
nct id: NCT01689935
lead sponsor: 
has dmc: Yes
This research study aims to compare different methods for helping difficult to treat or
      scarring (cystic) acne, ALA-PDT and i-PDT.

      There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been
      reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses
      a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.

      Levulan® is applied directly to facial/back acne. This is the way that it is usually applied.
      Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where
      the Levulan® was applied is exposed to a red light for activation.

      The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin
      through the skin pores to where the glands are. PDT destroys the glands reducing the acne
      lesion.

      Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure
      also has some side effects. Some of the side effects include pain, burning sensation during
      the procedure, and redness, tenderness, and swelling after the procedure.

      At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators
      developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT
      is aimed at reducing the side-effects of ALA- PDT.

      The difference between these two procedures is that i-PDT uses a light source that will
      prevent Levulan® accumulation in the normal skin surface. The investigators would like to
      find out if Levulan® will be placed only inside the sebaceous glands.
This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects
      will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the
      right and left. One half of the face or back will receive ALA-PDT and the other half will
      receive i-PDT. For subjects with back acne, red light and blue light alone will be applied
      for comparison.

      Healthy subjects with difficult to treat moderate or severe acne on the face or back are
      eligible to enroll.

      The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with
      follow-ups 1, 3 and 6 months after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
time frame: 0, 4, 8, 12, 16, 24 and 36 weeks
description: 0. Clear: No lesions but erythema and residual hyperpigmentation may be present
Almost Clear: few scattered comedones and a few (< five) small papules
Mild:< 50% face involved, many comedones/papules and pustules
Moderate:> 50% of face involved. Numerous comedones, papules and pustules
Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts.
1) Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.
measure: Pain reduction
time frame: During, immediately after and 24 h after treatment
description: Visual Pain Scale - 0 (no pain) -10 (severe pain)
measure: Side-effects Profile
time frame: Immediately after treatment and during follow-up visits
description: Evaluation of overall side-effects of each test site
arm group label: Control
arm group type: No Intervention
description: No drug, no treatment
arm group label: ALA-PDT
arm group type: Active Comparator
description: Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT
arm group label: i-PDT
arm group type: Experimental
description: Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
arm group label: Red Light only
arm group type: Active Comparator
description: Red light only - no drug
arm group label: Blue light only
arm group type: Active Comparator
description: Blue light only - no drug
intervention type: Drug
intervention name: 20 % Aminolevulinic Acid
description: topical medication for ALA-PDT and i-PDT
arm group label: ALA-PDT
arm group label: i-PDT
other name: 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)
intervention type: Device
intervention name: Red light only
description: Red Light therapy
arm group label: Red Light only
other name: Omnilux Revive
other name: 635 nm - LED (Phototherapeutics, Cheshire, UK)
intervention type: Device
intervention name: Blue light only
description: Blue light only
arm group label: Blue light only
arm group label: i-PDT
other name: Omnilux Blue
other name: 415 nm LED (Phototherapeutics, Cheshire, UK)
criteria: 
gender: All
minimum age: 14 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Rox Anderson, MD
role: Principal Investigator
affiliation: Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical Hospital
last name: Fernanda H Sakamoto, MD, PhD
role: Study Chair
affiliation: Wellman Center for Photomedicine - Massachusetts General Hospital - Harvard Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Richard Rox Anderson, MD
investigator title: Professor, Harvard Medical School (Dermatology)
mesh term: Acne Vulgaris
mesh term: Aminolevulinic Acid