<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/NCT03284333</url>
  </required_header>
  <id_info>
    <org_study_id>C-17-ML02</org_study_id>
    <nct_id>NCT03284333</nct_id>
  </id_info>
  <brief_title>enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars</brief_title>
  <official_title>Open-label, Prospective, Multicenter Study to Evaluate the Cutera enLighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate and Severe Acne Scars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cutera Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cutera Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pivotal investigation is to evaluate the efficacy and safety of the&#xD;
      Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser&#xD;
      and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne&#xD;
      scars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female&#xD;
      subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars.&#xD;
      Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the&#xD;
      Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be&#xD;
      contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will&#xD;
      return to the site after all study treatments have been delivered for two follow-up visits: 6&#xD;
      and 12 weeks (± 2 weeks) following their final study treatment.&#xD;
&#xD;
        1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final&#xD;
           treatment photographs from the baseline by at least two of the three blinded reviewers&#xD;
           in 75% of the patients and an improvement of one point in the ASAS.&#xD;
&#xD;
        2. The Secondary Efficacy Endpoints as the:&#xD;
&#xD;
             -  Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece&#xD;
                attachment treatment as assessed by the investigator starting from the 2nd&#xD;
                treatment onward, and&#xD;
&#xD;
             -  Subject satisfaction levels as assessed from the subject questionnaire completed at&#xD;
                the final follow-up visit 12 weeks post final treatment.&#xD;
&#xD;
        3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array&#xD;
           handpiece attachment as assessed by the frequency and severity of device related adverse&#xD;
           events,&#xD;
&#xD;
        4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens&#xD;
           Array handpiece attachment for the improvement of skin quality as assessed by the&#xD;
           investigator and/or blinded evaluators 12-weeks-post final study treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Actual">September 5, 2018</completion_date>
  <primary_completion_date type="Actual">September 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.</measure>
    <time_frame>12 weeks post-final treatment</time_frame>
    <description>visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Acne Scars - Mixed Atrophic and Hypertrophic</condition>
  <arm_group>
    <arm_group_label>other</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>other</intervention_name>
    <description>no arm</description>
    <arm_group_label>other</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be able to read, understand and sign the Informed Consent Form.&#xD;
&#xD;
          2. Female or Male, 18 to 65 years of age (inclusive).&#xD;
&#xD;
          3. Fitzpatrick Skin Type I - VI (Appendix 6).&#xD;
&#xD;
          4. Subject desires treatment for acne scars and wishes to undergo laser treatments for&#xD;
             improvement.&#xD;
&#xD;
          5. Subject has bilateral moderate to severe signs of facial acne scarring.&#xD;
&#xD;
          6. Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece&#xD;
             attachment treatments and able to adhere to the treatments, follow-up visit schedule,&#xD;
             and post-treatment care instructions.&#xD;
&#xD;
          7. Willing to have very limited sun exposure and use sunscreen on the treatment area&#xD;
             every day for the duration of the study, including the follow-up period.&#xD;
&#xD;
          8. Willing to have digital photographs taken of the treatment area and agree to use of&#xD;
             photographs for presentation (educational and/or marketing), publications, and any&#xD;
             additional marketing purposes.&#xD;
&#xD;
          9. Agree to not undergo any other procedure(s) or treatment(s) for acne scars during the&#xD;
             study and has no intention of having such procedures performed during the course of&#xD;
             the study.&#xD;
&#xD;
         10. For female subjects: not pregnant or lactating and is either post-menopausal,&#xD;
             surgically sterilized, or using a medically acceptable form of birth control at least&#xD;
             3 months prior to enrollment and during the entire course of the study.,&#xD;
&#xD;
             -&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
        1. Participation in a clinical trial of another drug, or device administered to the&#xD;
        treatment area, within 6 months prior to enrollment or during the study.&#xD;
&#xD;
        2. Any type of prior cosmetic treatment to the target area within 6 months of study&#xD;
        participation, such as laser procedures, facial fillers, i.e. (Bellafill) and those used&#xD;
        for general aesthetic correction, facial peel, lightening creams, or facial surgery.&#xD;
&#xD;
        3. Use of prescription topicals in the treatment area within one month prior to treatment&#xD;
        or use of topical agents one week prior to treatment that may cause facial sensitivity.&#xD;
&#xD;
        4. Suffering from significant skin conditions in the treated areas or inflammatory skin&#xD;
        conditions, including but not limited to, open lacerations or abrasions, hidradenitis,&#xD;
        rash, infection , or dermatitis of the treatment area prior to treatment (duration of&#xD;
        resolution as per the Investigator's discretion).&#xD;
&#xD;
        5. Pregnant and/or breastfeeding, or planning to become pregnant. 6. Significant concurrent&#xD;
        illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders&#xD;
        (including HIV infection or AIDS) or using immunosuppressive medication.&#xD;
&#xD;
        7. Hypersensitivity to light exposure. 8. Any use of medication that is known to increase&#xD;
        sensitivity to light according to the Investigator's discretion.&#xD;
&#xD;
        9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to&#xD;
        bruising.&#xD;
&#xD;
        10. Has a history of squamous cell carcinoma or melanoma in the treatment area. 11. History&#xD;
        of epidermal or dermal disorders (particularly if involving collagen or microvascularity),&#xD;
        including collagen vascular disease or vasculitic disorders.&#xD;
&#xD;
        12. A history or active skin condition that in the opinion of the Investigator may&#xD;
        interfere/confound with the treatment.&#xD;
&#xD;
        13. History of connective tissue disease, such as systemic lupus erythematosus or&#xD;
        scleroderma.&#xD;
&#xD;
        14. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes&#xD;
        zoster (shingles) in the treatment area, unless treatment is conducted following a&#xD;
        prophylactic regimen.&#xD;
&#xD;
        15. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation,&#xD;
        or any that are considered not acceptable by the study investigator.&#xD;
&#xD;
        16. Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000&#xD;
        units per day) within 12 months of initial treatment or plans on using during the course of&#xD;
        the study (note: skin must regain its normal degree of moisture prior to treatment, e.g.&#xD;
        lack of noticeable skin flaking and peeling).&#xD;
&#xD;
        17. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely&#xD;
        to refrain from tanning during the study.&#xD;
&#xD;
        19. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,)&#xD;
        that would interfere with diagnosis, assessment, and treatment.&#xD;
&#xD;
        20. As per the Investigator's discretion, any physical or mental condition which might make&#xD;
        it unsafe for the subject to participate in this study, including excessive alcohol or drug&#xD;
        abuses, or a condition that would compromise the subject's ability to comply with the study&#xD;
        requirements.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Ronan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cutera Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neil Sadick, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sadick Dermatology/Sadick Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cutera Research Center</name>
      <address>
        <city>Brisbane</city>
        <state>California</state>
        <zip>94005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sadick Dermatology/Sadick Research Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>July 14, 2023</results_first_submitted>
  <results_first_submitted_qc>July 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 1, 2023</results_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03284333/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>Treatment with the 1064nm laser</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>Treatment with the 1064nm laser</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </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="39.6" spread="14.9"/>
                  </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="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.</title>
        <description>visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)</description>
        <time_frame>12 weeks post-final treatment</time_frame>
        <population>Number of patients who completed at least 1 treatment and the 12 week follow up visit</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>Treatment with the 1064nm laser</description>
          </group>
        </group_list>
        <measure>
          <title>Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.</title>
          <description>visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)</description>
          <population>Number of patients who completed at least 1 treatment and the 12 week follow up visit</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during and following each treatment up to 12 weeks post final laser treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>Treatment with the 1064nm laser</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="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="43" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="43" subjects_affected="43" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="43"/>
              </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>Margot Doucette</name_or_title>
      <organization>Cutera</organization>
      <phone>415-357-5518</phone>
      <email>mdoucette@cutera.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/NCT03284333
org study id: C-17-ML02
nct id: NCT03284333
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the
      Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser
      and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne
      scars.
This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female
      subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars.
      Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the
      Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be
      contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will
      return to the site after all study treatments have been delivered for two follow-up visits: 6
      and 12 weeks (± 2 weeks) following their final study treatment.

        1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final
           treatment photographs from the baseline by at least two of the three blinded reviewers
           in 75% of the patients and an improvement of one point in the ASAS.

        2. The Secondary Efficacy Endpoints as the:

             -  Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece
                attachment treatment as assessed by the investigator starting from the 2nd
                treatment onward, and

             -  Subject satisfaction levels as assessed from the subject questionnaire completed at
                the final follow-up visit 12 weeks post final treatment.

        3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array
           handpiece attachment as assessed by the frequency and severity of device related adverse
           events,

        4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens
           Array handpiece attachment for the improvement of skin quality as assessed by the
           investigator and/or blinded evaluators 12-weeks-post final study treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
time frame: 12 weeks post-final treatment
description: visual review of study photographs correctly identifying the temporal order (before and after) of each photograph pair (Baseline and 12 week Post-final treatment)
arm group label: other
arm group type: Experimental
description: no arm
intervention type: Device
intervention name: other
description: no arm
arm group label: other
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Ronan, M.D.
role: Principal Investigator
affiliation: Cutera Research Center
last name: Neil Sadick, M.D.
role: Principal Investigator
affiliation: Sadick Dermatology/Sadick Research Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertrophy
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 