<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/NCT02218463</url>
  </required_header>
  <id_info>
    <org_study_id>CMH14010039</org_study_id>
    <nct_id>NCT02218463</nct_id>
  </id_info>
  <brief_title>Treatment of Prepubertal Labial Adhesions</brief_title>
  <official_title>Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Missouri, Kansas City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.&#xD;
      This study aims to evaluate an alternative and less costly option of treatment with&#xD;
      potentially less side effects.&#xD;
&#xD;
      Primary Hypothesis:&#xD;
&#xD;
      There will be a difference in complete resolution of labial adhesions with topical estrogen&#xD;
      with lateral traction as compared to an emollient with lateral traction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in&#xD;
      combination with vulvar irritation. For many years, first-line treatment for labial adhesions&#xD;
      in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of&#xD;
      labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of&#xD;
      treatment. However, because topical estrogen is systemically absorbed, its use is associated&#xD;
      with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There&#xD;
      is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical&#xD;
      estrogen. In addition, topical estrogen is costly. Therefore, there continues to be&#xD;
      controversy over the optimal treatment of labial adhesions in prepubertal girls.&#xD;
&#xD;
      Generally, for medical treatment of labial adhesions, topical estrogen is applied to the&#xD;
      adhesion whist applying gentle lateral traction to promote separation of the labia. It is,&#xD;
      therefore, plausible that the lateral traction applied to the adhesion site is what&#xD;
      ultimately results in the separation of the labial fusion, while the use of estrogen improves&#xD;
      healing after mechanical separation.&#xD;
&#xD;
      This is a single site, prospective, randomized, double-blinded study evaluating the&#xD;
      comparative effectiveness of topical estrogen with lateral traction versus topical emollient&#xD;
      with lateral traction for the treatment of labial adhesions in prepubertal girls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Resolution of Labial Adhesion.</measure>
    <time_frame>3 weeks and 6 weeks</time_frame>
    <description>The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite Severity Scale of Labial Adhesion Over Time</measure>
    <time_frame>3 weeks and 6 weeks</time_frame>
    <description>Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Prepubertal Labial Adhesions</condition>
  <arm_group>
    <arm_group_label>Cetaphil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Estradiol Cream 0.01%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol cream 0.01%</intervention_name>
    <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
    <arm_group_label>Estradiol Cream 0.01%</arm_group_label>
    <other_name>Estrace Vaginal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetaphil</intervention_name>
    <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
    <arm_group_label>Cetaphil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prepubertal girls ages 3 months to 12 years with labial adhesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of underlying dermatologic conditions such as lichen sclerosis, severe atopic&#xD;
             dermatitis, psoriasis or vitiligo&#xD;
&#xD;
          -  Presence of systemic conditions that can have vulvar manifestations such as Crohn's&#xD;
             disease and Behçet disease&#xD;
&#xD;
          -  Presence of disorders requiring immunosuppressant treatment&#xD;
&#xD;
          -  Previous surgical separation of labial adhesions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tazim Dowlut-McElroy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri, Kansas City</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie L Strickland, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>University of Missouri-Kansas City; Children's Mercy Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Hospitals &amp; Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>January 30, 2017</results_first_submitted>
  <results_first_submitted_qc>November 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2019</results_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Tazim Dowlut-McElroy</investigator_full_name>
    <investigator_title>Pediatric and Adolescent Gynecology Fellow</investigator_title>
  </responsible_party>
  <keyword>Vulvar disease, adhesions, topical therapy</keyword>
  <keyword>Labial adhesions prepubertal girls</keyword>
  <keyword>Labial agglutination</keyword>
  <keyword>Labial fusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cetaphil</title>
          <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
        </group>
        <group group_id="P2">
          <title>Estradiol Cream 0.01%</title>
          <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cetaphil</title>
          <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
        </group>
        <group group_id="B2">
          <title>Estradiol Cream 0.01%</title>
          <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</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="21"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" lower_limit="5" upper_limit="84"/>
                    <measurement group_id="B2" value="26" lower_limit="4" upper_limit="108"/>
                    <measurement group_id="B3" value="29" lower_limit="4" upper_limit="108"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</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>
                  <title>Male</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 and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>% introital closure</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>25%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Thickness of labial adhesion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Thin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intermediate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thick</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urinary tract infection</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vulvovaginitis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>
              <title>Absent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>Pain with activity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Postvoid dribbling</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Present</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absent</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Resolution of Labial Adhesion.</title>
        <description>The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.</description>
        <time_frame>3 weeks and 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil</title>
            <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
          </group>
          <group group_id="O2">
            <title>Estradiol Cream 0.01%</title>
            <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Resolution of Labial Adhesion.</title>
          <description>The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation 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="21"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Assessment of complete resolution between the 2 study arms.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.206</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Composite Severity Scale of Labial Adhesion Over Time</title>
        <description>Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion.</description>
        <time_frame>3 weeks and 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cetaphil</title>
            <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
          </group>
          <group group_id="O2">
            <title>Estradiol Cream 0.01%</title>
            <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Severity Scale of Labial Adhesion Over Time</title>
          <description>Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="3.1"/>
                    <measurement group_id="O2" value="6.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.4"/>
                    <measurement group_id="O2" value="1.5" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.1"/>
                    <measurement group_id="O2" value="1.6" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Time Effect</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment Effect</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.370</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment by time interaction</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.425</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cetaphil</title>
          <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Cetaphil: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</description>
        </group>
        <group group_id="E2">
          <title>Estradiol Cream 0.01%</title>
          <description>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily&#xD;
Estradiol cream 0.01%: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily</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="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Vulvar irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
              </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>Dr. Tazim Dowlut-McElroy, M.D., M.S.</name_or_title>
      <organization>University of Missouri-Kansas City School of Medicine</organization>
      <phone>816-404-5150</phone>
      <email>tdowlut@cmh.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/NCT02218463
org study id: CMH14010039
nct id: NCT02218463
lead sponsor: 
collaborator: 
has dmc: No
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen.
      This study aims to evaluate an alternative and less costly option of treatment with
      potentially less side effects.

      Primary Hypothesis:

      There will be a difference in complete resolution of labial adhesions with topical estrogen
      with lateral traction as compared to an emollient with lateral traction.
The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in
      combination with vulvar irritation. For many years, first-line treatment for labial adhesions
      in prepubertal girls has been topical estrogen. With the use of topical estrogen, 50% of
      labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of
      treatment. However, because topical estrogen is systemically absorbed, its use is associated
      with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There
      is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical
      estrogen. In addition, topical estrogen is costly. Therefore, there continues to be
      controversy over the optimal treatment of labial adhesions in prepubertal girls.

      Generally, for medical treatment of labial adhesions, topical estrogen is applied to the
      adhesion whist applying gentle lateral traction to promote separation of the labia. It is,
      therefore, plausible that the lateral traction applied to the adhesion site is what
      ultimately results in the separation of the labial fusion, while the use of estrogen improves
      healing after mechanical separation.

      This is a single site, prospective, randomized, double-blinded study evaluating the
      comparative effectiveness of topical estrogen with lateral traction versus topical emollient
      with lateral traction for the treatment of labial adhesions in prepubertal girls.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Complete Resolution of Labial Adhesion.
time frame: 3 weeks and 6 weeks
description: The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.
measure: Composite Severity Scale of Labial Adhesion Over Time
time frame: 3 weeks and 6 weeks
description: Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion.
arm group label: Cetaphil
arm group type: Active Comparator
description: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
arm group label: Estradiol Cream 0.01%
arm group type: Active Comparator
description: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
intervention type: Drug
intervention name: Estradiol cream 0.01%
description: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
arm group label: Estradiol Cream 0.01%
other name: Estrace Vaginal
intervention type: Drug
intervention name: Cetaphil
description: Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
arm group label: Cetaphil
criteria: 
gender: Female
minimum age: 3 Months
maximum age: 12 Years
healthy volunteers: No
last name: Tazim Dowlut-McElroy, MD
role: Principal Investigator
affiliation: University of Missouri, Kansas City
last name: Julie L Strickland, MD, MPH
role: Study Director
affiliation: University of Missouri-Kansas City; Children's Mercy Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Tazim Dowlut-McElroy
investigator title: Pediatric and Adolescent Gynecology Fellow
mesh term: Tissue Adhesions
mesh term: Estradiol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 