<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/NCT04425746</url>
  </required_header>
  <id_info>
    <org_study_id>CUV025</org_study_id>
    <nct_id>NCT04425746</nct_id>
  </id_info>
  <brief_title>Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium</brief_title>
  <official_title>A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinuvel Pharmaceuticals Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinuvel Pharmaceuticals Limited</source>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the safety and efficacy of afamelanotide&#xD;
      (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic&#xD;
      therapy using porfimer sodium.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2008</start_date>
  <completion_date type="Actual">May 28, 2009</completion_date>
  <primary_completion_date type="Actual">May 28, 2009</primary_completion_date>
  <phase>Phase 2</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>The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting</measure>
    <time_frame>From Day 04 to Day 90</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>From Day 0 to Day 20, Day 60 and Day 90</time_frame>
    <description>Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Patients Undergoing Photodynamic Therapy Using Porfimer Sodium</condition>
  <arm_group>
    <arm_group_label>Afamelanotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Afamelanotide</intervention_name>
    <arm_group_label>Afamelanotide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female Caucasian subjects undergoing photodynamic therapy with porfimer&#xD;
             sodium;&#xD;
&#xD;
          -  Aged greater than 18 years;&#xD;
&#xD;
          -  Written informed consent prior to the performance of any study-specific procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy or hypersensitivity to afamelanotide or the polymer contained in the&#xD;
             implant;&#xD;
&#xD;
          -  Non-Caucasian patients;&#xD;
&#xD;
          -  Personal history of melanoma or dysplastic nevus syndrome;&#xD;
&#xD;
          -  Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other&#xD;
             malignant or premalignant skin lesions;&#xD;
&#xD;
          -  Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to&#xD;
             baseline) or lactating;&#xD;
&#xD;
          -  Females of child-bearing potential (pre-menopausal, not surgically sterile) not using&#xD;
             adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide,&#xD;
             intrauterine device);&#xD;
&#xD;
          -  Participation in a simultaneous clinical trial for another investigational agent or&#xD;
             within 30 days prior to the screening visit;&#xD;
&#xD;
          -  Patients unable to give informed consent;&#xD;
&#xD;
          -  Patient needs for concomitant medication with potential photosensitizing effects e.g.&#xD;
             antibiotics like tetracyclines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>June 17, 2021</results_first_submitted>
  <results_first_submitted_qc>September 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2021</results_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Afamelanotide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Afamelanotide</title>
          <description>Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication, and the results of evaluation of phototoxicity.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Afamelanotide</title>
          <description>Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication, and the results of evaluation of phototoxicity.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.0" spread="9.3"/>
                    <measurement group_id="B2" value="72.6" spread="8.8"/>
                    <measurement group_id="B3" value="67.2" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting</title>
        <time_frame>From Day 04 to Day 90</time_frame>
        <population>The planned primary efficacy endpoint was the number of days for patients to be free of phototoxic reactions following phototesting. This was recorded by patients through diaries, however these diaries were not completed appropriately, thus data could not be collected. Thus, the efficacy analysis was performed using the secondary efficacy endpoint, change in quality of life as measured by SF-36.</population>
        <group_list>
          <group group_id="O1">
            <title>Afamelanotide</title>
            <description>Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.&#xD;
Afamelanotide</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting</title>
          <population>The planned primary efficacy endpoint was the number of days for patients to be free of phototoxic reactions following phototesting. This was recorded by patients through diaries, however these diaries were not completed appropriately, thus data could not be collected. Thus, the efficacy analysis was performed using the secondary efficacy endpoint, change in quality of life as measured by SF-36.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life</title>
        <description>Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
        <time_frame>From Day 0 to Day 20, Day 60 and Day 90</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Afamelanotide</title>
            <description>Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication, and the results of evaluation of phototoxicity.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life</title>
          <description>Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 20 - Day 0 (Physical functioning)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" lower_limit="-35.0" upper_limit="0.00"/>
                    <measurement group_id="O2" value="8.0" lower_limit="-15.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Role Physical)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.6" lower_limit="-56.3" upper_limit="6.3"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-18.8" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Bodily Pain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-28.0" upper_limit="78.0"/>
                    <measurement group_id="O2" value="-11.6" lower_limit="-68.0" upper_limit="59.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (General Health)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="-25.0" upper_limit="60.0"/>
                    <measurement group_id="O2" value="-27.6" lower_limit="-43.0" upper_limit="-13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Vitality)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" lower_limit="-18.8" upper_limit="12.5"/>
                    <measurement group_id="O2" value="-7.9" lower_limit="-18.8" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Social functioning)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="-50.0" upper_limit="50.0"/>
                    <measurement group_id="O2" value="7.5" lower_limit="-37.5" upper_limit="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Role - Emotional)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" lower_limit="-50.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="-25.0" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Mental Health)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="-20.0" upper_limit="35.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="-10.0" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Physical Component Summary)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" lower_limit="-13.1" upper_limit="2.7"/>
                    <measurement group_id="O2" value="-4.8" lower_limit="-18.4" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20 - Day 0 (Mental Component Summary)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="-12.1" upper_limit="10.4"/>
                    <measurement group_id="O2" value="2.7" lower_limit="-6.1" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Physical Functioning)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.6" lower_limit="-80.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="-10.0" lower_limit="-40.0" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Role- Physical)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.9" lower_limit="-56.3" upper_limit="12.5"/>
                    <measurement group_id="O2" value="-13.8" lower_limit="-43.8" upper_limit="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Bodily Pain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="-28.0" upper_limit="52.0"/>
                    <measurement group_id="O2" value="-21.4" lower_limit="-68.0" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (General Health)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" lower_limit="-32.0" upper_limit="18.0"/>
                    <measurement group_id="O2" value="-33.0" lower_limit="-47.0" upper_limit="-20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Vitality)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="-6.3" upper_limit="12.5"/>
                    <measurement group_id="O2" value="-5.4" lower_limit="-25.0" upper_limit="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Social Functioning)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-50.0" upper_limit="37.5"/>
                    <measurement group_id="O2" value="-17.5" lower_limit="-50.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Role- Emotional)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="-50.0" upper_limit="91.7"/>
                    <measurement group_id="O2" value="-10.0" lower_limit="-50.0" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Mental Health)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="-10.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-20.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Physical Component Summary)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" lower_limit="-23.7" upper_limit="7.7"/>
                    <measurement group_id="O2" value="-9.4" lower_limit="-18.4" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 60 - Day 0 (Mental Component Summary)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" lower_limit="-8.6" upper_limit="34.2"/>
                    <measurement group_id="O2" value="-2.5" lower_limit="-17.6" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Physical Functioning)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.6" lower_limit="-80.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="-5.0" lower_limit="-40.0" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Role- Physical)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-12.5" upper_limit="6.3"/>
                    <measurement group_id="O2" value="-3.8" lower_limit="-37.5" upper_limit="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Bodily pain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-16.0" upper_limit="19.0"/>
                    <measurement group_id="O2" value="-13.8" lower_limit="-69.0" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (General Health)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" lower_limit="-27.0" upper_limit="15.0"/>
                    <measurement group_id="O2" value="-32.0" lower_limit="-60.0" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Social Functioning)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-37.5" upper_limit="37.5"/>
                    <measurement group_id="O2" value="-12.5" lower_limit="-62.5" upper_limit="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Role- Emotional)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="-50.0" upper_limit="91.7"/>
                    <measurement group_id="O2" value="-11.7" lower_limit="-75.0" upper_limit="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Mental Health)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" lower_limit="-10.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="-9.0" lower_limit="-40.0" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Physical Component Summary)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" lower_limit="-23.7" upper_limit="8.2"/>
                    <measurement group_id="O2" value="-5.1" lower_limit="-14.7" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Day 0 (Mental Component Summary)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="-14.3" upper_limit="34.2"/>
                    <measurement group_id="O2" value="-6.3" lower_limit="-30.2" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>None of the serious adverse events were deemed to be related to study drug</desc>
      <group_list>
        <group group_id="E1">
          <title>Afamelanotide</title>
          <description>Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.&#xD;
Afamelanotide</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.&#xD;
Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oesophageal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Subdiaphragmatic abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Overdose of Previscan (Fluindione)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Drug toxicity (morphine)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations Manager</name_or_title>
      <organization>CLINUVEL PHARMACEUTICALS LTD</organization>
      <email>mail@clinuvel.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04425746
org study id: CUV025
nct id: NCT04425746
lead sponsor: 
The purpose of this study was to evaluate the safety and efficacy of afamelanotide
      (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic
      therapy using porfimer sodium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
time frame: From Day 04 to Day 90
measure: Change in Quality of Life
time frame: From Day 0 to Day 20, Day 60 and Day 90
description: Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
arm group label: Afamelanotide
arm group type: Experimental
description: Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
intervention type: Drug
intervention name: Afamelanotide
arm group label: Afamelanotide
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Afamelanotide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 