xml: <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/NCT06020586</url>
    </required_header>
    <id_info>
      <org_study_id>roffo</org_study_id>
      <nct_id>NCT06020586</nct_id>
    </id_info>
    <brief_title>Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.</brief_title>
    <official_title>Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto de Oncología Ángel H. Roffo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto de Oncología Ángel H. Roffo</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase 2, single-center study designed to determine the effect of ECOHAIR topical&#xD;
        solution on scalp hair growth evaluated objectively ( images) and subjectively ( patient and&#xD;
        investigator reports). A total of 22 subjects are planned to be enrolled, 15 in a prospective&#xD;
        single-arm phase in which they will receive the study treatment and 7 controls. Patients&#xD;
        should have a clinical diagnosis of chemotherapy-induced alopecia.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 6, 2022</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of scalp surface area covered at 30 days.</measure>
      <time_frame>30 days</time_frame>
      <description>The primary efficacy assessment is hair count in the target area (in a 1 cm2&#xD;
  circular area) using trichoscopy imaging.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.</measure>
      <time_frame>baseline-30 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Scalp hair density at 30 days.</measure>
      <time_frame>30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subject satisfaction questionnare.</measure>
      <time_frame>baseline-30 days</time_frame>
      <description>questionnaire is related to satisfaction with the outcome of the treatment (lotion).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of local skin reactions. severity according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)</measure>
      <time_frame>baseline- 60 days</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Chemotherapy-induced Alopecia</condition>
    <arm_group>
      <arm_group_label>hair lotion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>hair lotion</intervention_name>
      <description>ECOHAIR</description>
      <arm_group_label>hair lotion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women diagnosed with stage I to III breast/ovarian cancer aged 18 to 65 years.&#xD;
  &#xD;
            -  Receiving chemotherapeutic agents containing taxanes and/or anthracyclines.&#xD;
  &#xD;
            -  Willing to agree to shave thinning hair at baseline.&#xD;
  &#xD;
            -  Willingness to be photographed and consent to photographic disclosure.&#xD;
  &#xD;
            -  Able to understand and willing to sign an informed consent form.&#xD;
  &#xD;
            -  Willing and able to follow all study instructions and attend all study visits.&#xD;
  &#xD;
            -  Subjects taking thyroid replacement medication must be on stable doses for 6 months&#xD;
               prior to enrollment and remain on the same maintenance dose throughout the study.&#xD;
  &#xD;
            -  If female of childbearing age, must have a negative serum or urine pregnancy test at&#xD;
               screnning (visit 0). Use a highly effective method of contraception during the study;&#xD;
               do not plan a pregnancy for the duration of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of any products or devices used to promote scalp hair growth (e.g., finasteride or&#xD;
               minoxidil, L-tyrosine, cold caps).&#xD;
  &#xD;
            -  Sensitivity or allergy to any ingredient in the Ecohair product.&#xD;
  &#xD;
            -  Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or&#xD;
               history of skin disease on the scalp that, in the opinion of the investigator, may&#xD;
               interfere with the efficacy or safety evaluations of the study.&#xD;
  &#xD;
            -  Active scalp trauma or other condition affecting the scalp that, in the opinion of the&#xD;
               investigator may interfere with the conduct of the study or evaluations.&#xD;
  &#xD;
            -  The presence of a permanent or difficult to remove hairpiece or wig that, in the&#xD;
               opinion of the investigator, will interfere with study evaluations if not removed at&#xD;
               each visit.&#xD;
  &#xD;
            -  Failure to be able to perform assigned clinical visits.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Instituto Roffo</name>
        <address>
          <city>Caba</city>
          <state>Buenos Aires</state>
          <zip>1417</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria F Guerra</last_name>
        <phone>011 5287-5219</phone>
        <email>mariaflorenciaguerra87@gmail.com</email>
      </contact>
      <contact_backup>
        <phone_ext>Guerra</phone_ext>
        <email>mariaflorenciaguerra87@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Florencia Guerra, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Argentina</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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>Alopecia</mesh_term>
      <mesh_term>Alopecia Areata</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020586
  org study id: roffo
  nct id: NCT06020586
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase 2, single-center study designed to determine the effect of ECOHAIR topical
        solution on scalp hair growth evaluated objectively ( images) and subjectively ( patient and
        investigator reports). A total of 22 subjects are planned to be enrolled, 15 in a prospective
        single-arm phase in which they will receive the study treatment and 7 controls. Patients
        should have a clinical diagnosis of chemotherapy-induced alopecia.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of scalp surface area covered at 30 days.
  time frame: 30 days
  description: The primary efficacy assessment is hair count in the target area (in a 1 cm2
  circular area) using trichoscopy imaging.
  measure: Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.
  time frame: baseline-30 days
  measure: Scalp hair density at 30 days.
  time frame: 30 days
  measure: Subject satisfaction questionnare.
  time frame: baseline-30 days
  description: questionnaire is related to satisfaction with the outcome of the treatment (lotion).
  measure: Incidence and severity of local skin reactions. severity according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
  time frame: baseline- 60 days
  arm group label: hair lotion
  arm group type: Experimental
  intervention type: Other
  intervention name: hair lotion
  description: ECOHAIR
  arm group label: hair lotion
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Argentina
  responsible party type: Sponsor
  mesh term: Alopecia
  mesh term: Alopecia Areata