<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/NCT03831334</url>
  </required_header>
  <id_info>
    <org_study_id>JNC01142017</org_study_id>
    <nct_id>NCT03831334</nct_id>
  </id_info>
  <brief_title>Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia</brief_title>
  <official_title>An Open Label, Pilot Study Evaluating the Effect of Low-Dose Oral Minoxidil as Treatment of Permanent Chemotherapy-Induced Alopecia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      An open label, pilot study involving the use of low dose oral minoxidil to treat permanent&#xD;
      chemotherapy-induced alopecia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be evaluated through clinical assessment, histology, quality of life&#xD;
      assessment, and adverse event monitoring. The data gathered from this study will be used to&#xD;
      determine the safety and efficacy of the treatment regimen for this subset of CIA patients.&#xD;
      The oral minoxidil regimen will be considered effective if significant clinical regrowth,&#xD;
      positive histological changes, and improved Quality of Life are reported after the onset of&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 9, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Early Phase 1</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>Change in degree of hair regrowth using the IPAQ scale</measure>
    <time_frame>48 weeks</time_frame>
    <description>Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Investigator Photographic Assessment Questionnaire (IPAQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in degree of hair regrowth using the Dean Scale</measure>
    <time_frame>48 weeks</time_frame>
    <description>Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Dean Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>48 weeks</time_frame>
    <description>Evaluation will be performed by the investigators at every other visit (every 24 weeks) until the end of the study (48 weeks total).The quality of life endpoint will be assessed with the Dermatology Life Quality Index (DLQI) as reported by the subject.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Permanent Chemotherapy-induced Alopecia</condition>
  <arm_group>
    <arm_group_label>Minoxidil Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose oral minoxidil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral minoxidil</intervention_name>
    <description>Participants will be provided with minoxidil (2.5 mg tablets) for 90 days (45 tablets + 5 extra in case of splitting difficulty) of treatment drug in dispensing containers and instructed to take half a pill (1.25mg), once a day.</description>
    <arm_group_label>Minoxidil Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a clinical diagnosis of permanent chemotherapy-induced alopecia who&#xD;
             completed chemotherapy ≥ 6 months from the date of registration.&#xD;
&#xD;
          -  Patients must be age ≥ 18 years.&#xD;
&#xD;
          -  Females of child-bearing potential (FOCBP) and males must agree to use adequate&#xD;
             contraception (e.g., hormonal contraceptives such as birth control pills, patch,&#xD;
             intrauterine device; barrier contraception such as male/female condoms, diaphragm;&#xD;
             male partner with vasectomy; abstinence) prior to study entry, for the duration of&#xD;
             study participation, and for 30 days following completion of therapy.&#xD;
&#xD;
        Should a female patient become pregnant or suspect she is pregnant while participating in&#xD;
        this study, she should inform her treating physician immediately.&#xD;
&#xD;
        NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal&#xD;
        ligation, or remaining celibate by choice) who meets the following criteria: Has not&#xD;
        undergone a hysterectomy or bilateral oophorectomy Has had menses at any time in the&#xD;
        preceding 12 consecutive months (and therefore has not been naturally postmenopausal for &gt;&#xD;
        12 months)&#xD;
&#xD;
          -  FOCBP must have a negative urine or serum pregnancy test within 7 days prior to&#xD;
             registration on study.&#xD;
&#xD;
          -  Patients must have the ability to understand and the willingness to sign a written&#xD;
             informed consent prior to registration in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving any other investigational agents or using other alopecia treatments&#xD;
             in the past 3 months are not eligible.&#xD;
&#xD;
          -  Patients currently undergoing systemic cancer treatment or within 6 months of&#xD;
             finishing chemotherapy are not eligible. Note: Patients receiving hormone modulators&#xD;
             are eligible.&#xD;
&#xD;
          -  Patients who have pheochromocytoma, hypothyroidism, anemia, cutaneous GVHD,&#xD;
             hypotension, or a history of hypersensitivity to any components of the drug&#xD;
             preparation are not eligible.&#xD;
&#xD;
          -  Patients who have other forms of alopecia besides PCIA (with the exception of female&#xD;
             pattern Ludwig 1 alopecia) are not eligible.&#xD;
&#xD;
          -  Patients on oral or injectable anticoagulants are not eligible to participate in the&#xD;
             optional punch biopsy&#xD;
&#xD;
          -  Patients who have an uncontrolled intercurrent illness including, but not limited to&#xD;
             any of the following, are not eligible: (Uncontrolled Hypertension, Ongoing or active&#xD;
             infection requiring systemic treatment, Symptomatic congestive heart failure, Unstable&#xD;
             angina pectoris, Cardiac arrhythmia, Pericardial effusion, Psychiatric illness/social&#xD;
             situations that would limit compliance with study requirements, Patients with any&#xD;
             other illness or condition that the treating investigator feels would interfere with&#xD;
             study compliance or would compromise the patient's safety or study endpoints.)&#xD;
&#xD;
          -  Patients currently taking guanethidine are not eligible. Patients may participate&#xD;
             after a 1-week washout period.&#xD;
&#xD;
          -  Patients currently taking drugs that may enhance the hypotensive effect of minoxidil&#xD;
             are not eligible. Please contact study team regarding specific drug as washout period,&#xD;
             as this will vary. Note: This includes: Alfuzosin, Amifostine, antipsychotic agents,&#xD;
             Atazanavir, barbiturates, Benperidol, Brimonidine, Dapoxetine, Diazoxide, DULoxetine,&#xD;
             Levodopa, Lormetazepam, Molsidomine, Naftopidil, Nicergoline, Nicorandil,&#xD;
             Nitroprusside, Obinutuzumab, Pentoxifylline, phosphodiesterase 5 inhibitors,&#xD;
             Probenecid, prostacyclin analogues, Quinagolide, and Valproate. If a patient is&#xD;
             currently taking any of these drugs, further evaluation will be required to determine&#xD;
             eligibility.&#xD;
&#xD;
          -  Female patients who are pregnant or nursing are not eligible.&#xD;
&#xD;
          -  Patients who have any condition or situation which, in the investigator's opinion,&#xD;
             puts the patient at significant risk, could confound the study results, or may&#xD;
             interfere significantly with the patient's participation in the study are not&#xD;
             eligible.&#xD;
&#xD;
          -  Patients who are unable to communicate or cooperate with the investigator due to&#xD;
             language problems, poor mental development, or impaired cerebral function are not&#xD;
             eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer N Choi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer N Choi, MD</last_name>
    <phone>312-695-8106</phone>
    <email>jennifer.choi@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>DermCTU</last_name>
    <phone>312-504-5944</phone>
    <email>NUdermatologyCTU@northwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer N Choi, MD</last_name>
      <phone>312-695-8106</phone>
      <email>jennifer.choi@northwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>DermCTU</last_name>
      <phone>312-503-5944</phone>
      <email>NUdermatologyCTU@northwestern.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Jennifer Nam Choi, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minoxidil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03831334
org study id: JNC01142017
nct id: NCT03831334
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
An open label, pilot study involving the use of low dose oral minoxidil to treat permanent
      chemotherapy-induced alopecia.
Patients will be evaluated through clinical assessment, histology, quality of life
      assessment, and adverse event monitoring. The data gathered from this study will be used to
      determine the safety and efficacy of the treatment regimen for this subset of CIA patients.
      The oral minoxidil regimen will be considered effective if significant clinical regrowth,
      positive histological changes, and improved Quality of Life are reported after the onset of
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in degree of hair regrowth using the IPAQ scale
time frame: 48 weeks
description: Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Investigator Photographic Assessment Questionnaire (IPAQ)
measure: Change in degree of hair regrowth using the Dean Scale
time frame: 48 weeks
description: Evaluation will be performed by the investigators at each visit (every 12 weeks) as measured by the Dean Scale
measure: Change in quality of life
time frame: 48 weeks
description: Evaluation will be performed by the investigators at every other visit (every 24 weeks) until the end of the study (48 weeks total).The quality of life endpoint will be assessed with the Dermatology Life Quality Index (DLQI) as reported by the subject.
arm group label: Minoxidil Treatment
arm group type: Experimental
description: Low dose oral minoxidil
intervention type: Drug
intervention name: oral minoxidil
description: Participants will be provided with minoxidil (2.5 mg tablets) for 90 days (45 tablets + 5 extra in case of splitting difficulty) of treatment drug in dispensing containers and instructed to take half a pill (1.25mg), once a day.
arm group label: Minoxidil Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer N Choi, MD
role: Principal Investigator
affiliation: Northwestern University
last name: Jennifer N Choi, MD
phone: 312-695-8106
email: jennifer.choi@northwestern.edu
last name: DermCTU
phone: 312-504-5944
email: NUdermatologyCTU@northwestern.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Jennifer Nam Choi, MD
investigator title: Principal Investigator
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Minoxidil
sharing ipd: No