<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/NCT03037541</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00014209</org_study_id>
    <nct_id>NCT03037541</nct_id>
  </id_info>
  <brief_title>Cryosurgery and Cream Combination for Actinic Keratosis</brief_title>
  <official_title>A Single-Center, Randomized, Single-Blinded, Placebo-Controlled Trial on the Efficacy of Cryosurgery and 5-Fluorouracil 0.5% Cream Combination Therapy for the Treatment of Actinic Keratosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as&#xD;
      tolerated, though local irritation often occurs within the first week of treatment and&#xD;
      increases in a dose-dependent manner. In this study, the investigators will examine the&#xD;
      combination of standard cryosurgery treatment followed by a shortened course of topical&#xD;
      fluorouracil cram. The investigators anticipate that a one week treatment course will&#xD;
      maintain overall effectiveness when combined with previous cryosurgery, but will reduce the&#xD;
      overall adverse effects of topical therapy due to the reduced treatment time and the presence&#xD;
      of fewer baseline lesions to treat. This treatment approach may provide a more acceptable&#xD;
      risk/benefit ratio option for patients with more extensive disease and simplify standard&#xD;
      combination treatment options. The primary objective is to evaluate the efficacy of&#xD;
      combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and&#xD;
      placebo in the treatment of actinic keratosis lesions. The efficacy of this combination&#xD;
      therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter&#xD;
      will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (1:1), single-blind, placebo controlled, single center prospective&#xD;
      study. Subjects will first undergo cryosurgery of all clinically apparent AK lesions, limited&#xD;
      to the face or balding scalp. Three weeks after cryosurgery, subjects will then be randomized&#xD;
      (1:1 according to standard randomization tables) and directed to apply either Carac 0.5%&#xD;
      cream or placebo cream (Cetaphil Cream) to the face or balding scalp at bedtime for seven&#xD;
      consecutive days, washed off each following morning. Each does of study cream will be applied&#xD;
      at approximately the same time of day and will remain on the skin for approximately eight&#xD;
      hours. Subject evaluation, Investigator Global Assessments, Quality of Life lesion counts and&#xD;
      photography shall be performed at Baseline. At Week 3, study drug will be dispensed and the&#xD;
      global assessments and assessment of improvement will be performed. A Medication Tolerability&#xD;
      Assessment will occur at Week 4 when the study drug will be returned. Investigator Global&#xD;
      Assessment, lesion count, Global Assessment of Improvement and Quality of Life will be&#xD;
      measured at Week 8 and Week 26 (or end of study). Photography will be done at Week 26 or end&#xD;
      of study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2011</start_date>
  <completion_date type="Actual">October 29, 2013</completion_date>
  <primary_completion_date type="Actual">October 29, 2013</primary_completion_date>
  <phase>Phase 3</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number Participants With 100% Clearance</measure>
    <time_frame>24 weeks</time_frame>
    <description>The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With 75% Clearance</measure>
    <time_frame>24 weeks</time_frame>
    <description>The secondary endpoint is number of participants that receive 75 % clearance of</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Actinic Keratosis</condition>
  <arm_group>
    <arm_group_label>Group 1 Carac (fluorouracil) 0.5% cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carac cream (fluorouracil) 0.5% applied daily on the face for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Cetaphil cream applied daily on the face for one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carac Cream</intervention_name>
    <description>Carac Cream will be used once daily for seven consecutive days</description>
    <arm_group_label>Group 1 Carac (fluorouracil) 0.5% cream</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Cetaphil cream</intervention_name>
    <description>Placebo Cetaphil Cream will be used once daily for seven consecutive days</description>
    <arm_group_label>Group 2 Placebo</arm_group_label>
    <other_name>Cetaphil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be male or female and at least 18 years of age. Each subject must demonstrate&#xD;
             good health as determined by a baseline medical history.&#xD;
&#xD;
          -  Female subjects myst be of either non-childbearing potential, or childbearing&#xD;
             potential provided: negative urine pregnancy test and using two acceptable methods of&#xD;
             effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal&#xD;
             ligation, vasectomy of the partner in a monogamous relationship, condoms and&#xD;
             spermicidal form or gel and/or cervical cap or sponge), as determined by the&#xD;
             investigator&#xD;
&#xD;
          -  At least eight clinically typical, visible and discrete AK lesions within the&#xD;
             treatment area on the face or balding scalp&#xD;
&#xD;
          -  Subjects must be able and willing to comply with study procedures and have provided&#xD;
             written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision,&#xD;
             curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing)&#xD;
             within the selected treatment area in the previous four weeks.&#xD;
&#xD;
          -  Treatment with systemic medications that suppress the immune system within the&#xD;
             previous four weeks.&#xD;
&#xD;
          -  Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or&#xD;
             more widespread field treatment with dermabrasion, medium or greater depth chemical&#xD;
             peel, or laser resurfacing within the previous six months.&#xD;
&#xD;
          -  Any known dihydropyrimidine dehydrogenase enzyme deficiency.&#xD;
&#xD;
          -  In addition, subjects who have any skin condition or disease that may require&#xD;
             concurrent therapy or may confound the evaluation as determined by the investigator,&#xD;
             or a history of hypersensitivity to any of the formulation components will be excluded&#xD;
             from study.&#xD;
&#xD;
          -  Subjects may not use other topical agents such as glycolic acid products,&#xD;
             alpha-hydroxy acid products, retinoids and chemical peel agents on teh treatment area&#xD;
             while on study. The use of these products are not allowed four weeks prior to study&#xD;
             enrollment. Introduction of any other prescription medication, topical or systemic for&#xD;
             actinic keratosis while participating in the study is not permitted.&#xD;
&#xD;
          -  Pregnant women, women who are breast feeding, or women of childbearing potential who&#xD;
             are not practicing two acceptable methods of effective contraception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Jorizzo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences Department of Dermatology</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 8, 2011</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>January 31, 2017</results_first_submitted>
  <results_first_submitted_qc>January 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2017</results_first_posted>
  <last_update_submitted>July 30, 2018</last_update_submitted>
  <last_update_submitted_qc>July 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wake Forest</keyword>
  <keyword>Actinic Keratosis</keyword>
  <keyword>Cryosurgery</keyword>
  <keyword>Cream</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1 Carac (Fluorouracil) 0.5% Cream</title>
          <description>Carac cream (fluorouracil) 0.5% applied daily on the face for one week&#xD;
Carac Cream: Carac Cream will be used once daily for seven consecutive days</description>
        </group>
        <group group_id="P2">
          <title>Group 2 Placebo</title>
          <description>Placebo Cetaphil cream applied daily on the face for one week&#xD;
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1 Carac (Fluorouracil) 0.5% Cream</title>
          <description>Carac cream (fluorouracil) 0.5% applied daily on the face for one week&#xD;
Carac Cream: Carac Cream will be used once daily for seven consecutive days</description>
        </group>
        <group group_id="B2">
          <title>Group 2 Placebo</title>
          <description>Placebo Cetaphil cream applied daily on the face for one week&#xD;
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number Participants With 100% Clearance</title>
        <description>The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1 Carac (Fluorouracil) 0.5% Cream</title>
            <description>Carac cream (fluorouracil) 0.5% applied daily on the face for one week&#xD;
Carac Cream: Carac Cream will be used once daily for seven consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Group 2 Placebo</title>
            <description>Placebo Cetaphil cream applied daily on the face for one week&#xD;
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Number Participants With 100% Clearance</title>
          <description>The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With 75% Clearance</title>
        <description>The secondary endpoint is number of participants that receive 75 % clearance of</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1 Carac (Fluorouracil) 0.5% Cream</title>
            <description>Carac cream (fluorouracil) 0.5% applied daily on the face for one week&#xD;
Carac Cream: Carac Cream will be used once daily for seven consecutive days</description>
          </group>
          <group group_id="O2">
            <title>Group 2 Placebo</title>
            <description>Placebo Cetaphil cream applied daily on the face for one week&#xD;
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With 75% Clearance</title>
          <description>The secondary endpoint is number of participants that receive 75 % clearance of</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Group 1 Carac (Fluorouracil) 0.5% Cream</title>
          <description>Carac cream (fluorouracil) 0.5% applied daily on the face for one week&#xD;
Carac Cream: Carac Cream will be used once daily for seven consecutive days</description>
        </group>
        <group group_id="E2">
          <title>Group 2 Placebo</title>
          <description>Placebo Cetaphil cream applied daily on the face for one week&#xD;
Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>tooth pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>joint pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>basal cell carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Joseph Jorizzo, MD</name_or_title>
      <organization>Wake Forest University Health Sciences</organization>
      <phone>336-716-3775</phone>
      <email>jjorizzo@wakehealth.edu</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/NCT03037541
org study id: IRB00014209
nct id: NCT03037541
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as
      tolerated, though local irritation often occurs within the first week of treatment and
      increases in a dose-dependent manner. In this study, the investigators will examine the
      combination of standard cryosurgery treatment followed by a shortened course of topical
      fluorouracil cram. The investigators anticipate that a one week treatment course will
      maintain overall effectiveness when combined with previous cryosurgery, but will reduce the
      overall adverse effects of topical therapy due to the reduced treatment time and the presence
      of fewer baseline lesions to treat. This treatment approach may provide a more acceptable
      risk/benefit ratio option for patients with more extensive disease and simplify standard
      combination treatment options. The primary objective is to evaluate the efficacy of
      combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and
      placebo in the treatment of actinic keratosis lesions. The efficacy of this combination
      therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter
      will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.
This is a randomized (1:1), single-blind, placebo controlled, single center prospective
      study. Subjects will first undergo cryosurgery of all clinically apparent AK lesions, limited
      to the face or balding scalp. Three weeks after cryosurgery, subjects will then be randomized
      (1:1 according to standard randomization tables) and directed to apply either Carac 0.5%
      cream or placebo cream (Cetaphil Cream) to the face or balding scalp at bedtime for seven
      consecutive days, washed off each following morning. Each does of study cream will be applied
      at approximately the same time of day and will remain on the skin for approximately eight
      hours. Subject evaluation, Investigator Global Assessments, Quality of Life lesion counts and
      photography shall be performed at Baseline. At Week 3, study drug will be dispensed and the
      global assessments and assessment of improvement will be performed. A Medication Tolerability
      Assessment will occur at Week 4 when the study drug will be returned. Investigator Global
      Assessment, lesion count, Global Assessment of Improvement and Quality of Life will be
      measured at Week 8 and Week 26 (or end of study). Photography will be done at Week 26 or end
      of study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number Participants With 100% Clearance
time frame: 24 weeks
description: The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment
measure: Number of Participants With 75% Clearance
time frame: 24 weeks
description: The secondary endpoint is number of participants that receive 75 % clearance of
arm group label: Group 1 Carac (fluorouracil) 0.5% cream
arm group type: Experimental
description: Carac cream (fluorouracil) 0.5% applied daily on the face for one week
arm group label: Group 2 Placebo
arm group type: Placebo Comparator
description: Placebo Cetaphil cream applied daily on the face for one week
intervention type: Drug
intervention name: Carac Cream
description: Carac Cream will be used once daily for seven consecutive days
arm group label: Group 1 Carac (fluorouracil) 0.5% cream
intervention type: Drug
intervention name: Placebo Cetaphil cream
description: Placebo Cetaphil Cream will be used once daily for seven consecutive days
arm group label: Group 2 Placebo
other name: Cetaphil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Joseph Jorizzo, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 