<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/NCT02250859</url>
  </required_header>
  <id_info>
    <org_study_id>FMX101-1</org_study_id>
    <nct_id>NCT02250859</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetic Study of Minocycline in Male and Female Volunteers</brief_title>
  <official_title>An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vyne Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vyne Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101&#xD;
      4% foam product in male and female some of which are with acne&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single-center, non-randomized, multiple-administrations study in males&#xD;
      and females, some of which are with acne.&#xD;
&#xD;
      Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline&#xD;
      (4%) foam for sixteen consecutive days.&#xD;
&#xD;
      Each subject will undergo screening procedures within 21 days prior to dosing, to assess his&#xD;
      eligibility to participate in the study, including a dermatological assessment of the acne&#xD;
      severity and distribution (for subjects with acne).&#xD;
&#xD;
      On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety&#xD;
      Follow-up visit will take place on 7-10 days after last dose, which will also include a&#xD;
      dermatological assessment of response to treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>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>adverse events</measure>
    <time_frame>22-25 days</time_frame>
    <description>AEs will be assessed starting from informed consent signature until end of study)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>irritation and local reaction</measure>
    <time_frame>16 days</time_frame>
    <description>The application area will be examined for irritation and local reaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in vital signs</measure>
    <time_frame>22-25 days</time_frame>
    <description>sitting BP, HR, RR, oral temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>16 days</time_frame>
    <description>will be assessed after 1 and 16 days of dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>16 days</time_frame>
    <description>will be assessed after 1 and 16 days of dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCT</measure>
    <time_frame>16 days</time_frame>
    <description>will be assessed after 1 and 16 days of dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T½</measure>
    <time_frame>16 days</time_frame>
    <description>will be assessed after 1 and 16 days of dosing</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Acne</condition>
  <arm_group>
    <arm_group_label>FMX101 Minocycline 4% foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMX101, Minocycline 4% foam</intervention_name>
    <description>FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days</description>
    <arm_group_label>FMX101 Minocycline 4% foam</arm_group_label>
    <other_name>FMX101 antibiotic foam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women between 18 and 35 years (inclusive) of age.&#xD;
&#xD;
          2. Clear skin or facial acne of any severity, currently untreated&#xD;
&#xD;
          3. Otherwise healthy subjects&#xD;
&#xD;
          4. Subjects who provide written informed consent to participate in the study.&#xD;
&#xD;
          5. Women of childbearing potential who are willing to use 2 reliable methods of&#xD;
             contraception or practice abstinence during the study period or be surgically&#xD;
             sterilized and agree to undergo repeated pregnancy tests.&#xD;
&#xD;
          6. Body Mass Index (BMI) 19.0 to &lt;30.0 kg/m2 and weight ranging between 60-90 kg (males)&#xD;
             and 50-85 (females).&#xD;
&#xD;
          7. Non-smoking and no use of any tobacco or nicotine products (by declaration) for a&#xD;
             period of at least 6 months prior to screening visit&#xD;
&#xD;
          8. Subjects in general good health in the opinion of the investigator as determined by&#xD;
             medical history, vital signs, ECG and a physical examination.&#xD;
&#xD;
          9. Shaven facial hair (males)&#xD;
&#xD;
         10. Negative HIV, Hepatitis B and Hepatitis C serology tests at screening.&#xD;
&#xD;
         11. No clinically significant abnormalities in hematology, blood chemistry, or urinalysis&#xD;
             lab tests at screening.&#xD;
&#xD;
         12. No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse&#xD;
             determined within 21 days of the start of the study (screening visit).&#xD;
&#xD;
         13. Willingness to minimize exposure to sun for 20 days after first dosing&#xD;
&#xD;
         14. Subjects must be able to understand the requirements of the study and must be willing&#xD;
             to comply with the requirements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Documented history or ongoing symptoms of significant neurological, renal,&#xD;
             cardiovascular, respiratory (asthma), endocrinological, gastrointestinal,&#xD;
             hematopoietic disease, neoplasm or any other clinically significant medical disorder,&#xD;
             which in the investigator's judgment contraindicate administration of the study&#xD;
             medications.&#xD;
&#xD;
          2. Known or suspected pregnancy or lactation or planned pregnancy during the study&#xD;
             duration (females)&#xD;
&#xD;
          3. Use of topical antibiotics or topical corticosteroids for acne treatment within the&#xD;
             past 2 weeks.&#xD;
&#xD;
          4. Use of systemic corticosteroids within the past 4 weeks.&#xD;
&#xD;
          5. Use of systemic retinoids (e.g. isotretinoin) within the past 6 months.&#xD;
&#xD;
          6. Concurrent use of medications known to be photosensitizers because of the possibility&#xD;
             of augmented photosensitivity.&#xD;
&#xD;
          7. History or evidence of skin conditions other than acne (eg, eczema) that would&#xD;
             interfere with the subject's participation in the study.&#xD;
&#xD;
          8. Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or&#xD;
             dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for&#xD;
             symptomatic relief of pain is allowed until 24 hours prior to the study drug&#xD;
             administration.&#xD;
&#xD;
          9. Dermatological conditions which might have an effect upon dermal application, e.g.:&#xD;
             Psoriasis, mycosis fungoides, widespread acne, facial or back dermatophytosis, severe&#xD;
             hyperhydrosis, chronic or recurrent skin infections, ichtyosis&#xD;
&#xD;
         10. Excessive hair in the intended application areas&#xD;
&#xD;
         11. Current or recent (within 1year) drug or alcohol abuse.&#xD;
&#xD;
         12. Known contraindication, hypersensitivity and/or allergy to the study drug or its&#xD;
             excipients.&#xD;
&#xD;
         13. Subjects with significant allergic response to other drugs&#xD;
&#xD;
         14. Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug&#xD;
             administration, which is considered of significance by the Principal Investigator.&#xD;
&#xD;
         15. Participation in another clinical trial with drugs received within 3 months prior to&#xD;
             dosing (calculated from the previous study's last dosing date).&#xD;
&#xD;
         16. Subjects who donated blood in the three months or received blood or plasma derivatives&#xD;
             in the six months preceding study drug administration.&#xD;
&#xD;
         17. Subjects unable to communicate well with the investigators and CRC staff (i.e.,&#xD;
             language problem, poor mental development or impaired cerebral function).&#xD;
&#xD;
         18. Subjects who are non-cooperative or unwilling to sign consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacob Atsmon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sourasky Medical center, Tel-aviv, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sourasky Medical Center, Clinical Research Center</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Minocycline</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02250859
org study id: FMX101-1
nct id: NCT02250859
lead sponsor: 
has dmc: No
The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101
      4% foam product in male and female some of which are with acne
This is an open-label, single-center, non-randomized, multiple-administrations study in males
      and females, some of which are with acne.

      Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline
      (4%) foam for sixteen consecutive days.

      Each subject will undergo screening procedures within 21 days prior to dosing, to assess his
      eligibility to participate in the study, including a dermatological assessment of the acne
      severity and distribution (for subjects with acne).

      On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety
      Follow-up visit will take place on 7-10 days after last dose, which will also include a
      dermatological assessment of response to treatment
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: adverse events
time frame: 22-25 days
description: AEs will be assessed starting from informed consent signature until end of study)
measure: irritation and local reaction
time frame: 16 days
description: The application area will be examined for irritation and local reaction
measure: Change from baseline in vital signs
time frame: 22-25 days
description: sitting BP, HR, RR, oral temperature
measure: Cmax
time frame: 16 days
description: will be assessed after 1 and 16 days of dosing
measure: Tmax
time frame: 16 days
description: will be assessed after 1 and 16 days of dosing
measure: AUCT
time frame: 16 days
description: will be assessed after 1 and 16 days of dosing
measure: T½
time frame: 16 days
description: will be assessed after 1 and 16 days of dosing
arm group label: FMX101 Minocycline 4% foam
arm group type: Experimental
description: FMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin
intervention type: Drug
intervention name: FMX101, Minocycline 4% foam
description: FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days
arm group label: FMX101 Minocycline 4% foam
other name: FMX101 antibiotic foam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob Atsmon, MD
role: Principal Investigator
affiliation: Sourasky Medical center, Tel-aviv, Israel
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Anti-Bacterial Agents
mesh term: Minocycline