<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/NCT03009734</url>
  </required_header>
  <id_info>
    <org_study_id>DECOLAD</org_study_id>
    <nct_id>NCT03009734</nct_id>
  </id_info>
  <brief_title>Evaluation of ATx201 as a Topical Antibiotic Agent</brief_title>
  <official_title>A Prospective, Single Center, Randomized, Double-blind, Placebo Controlled Study in Two Phases to Evaluate the Safety and Efficacy of ATx201 as a Topical Antibiotic Agent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNION therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNION therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      AntibioTx is developping ATx201 as a topical product for treatment of skin infections,&#xD;
      including infected atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity&#xD;
      of or resistance towards the main topical antibiotics. Accordingly, the infections are either&#xD;
      not effectively treated or harsher systemic antibiotics with side effects are needed.&#xD;
&#xD;
      Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various&#xD;
      species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms.&#xD;
      ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus&#xD;
      aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all&#xD;
      topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the&#xD;
      onset of de novo resistance compared to currently marketed antibiotics.&#xD;
&#xD;
      The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients.&#xD;
&#xD;
      The primary objective is to demonstrate the safety and tolerability of new topical&#xD;
      formulations of ATx201 in healthy volunteers, and in a population of patients with infected&#xD;
      atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4&#xD;
      and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of&#xD;
      ATx201 including the respective Placebos will be applied to healthy volunteers. One&#xD;
      formulation will advance into Phase II, where patients will be treated with the respective&#xD;
      formulation or Placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Safety and tolerability of new topical formulations of ATx201</measure>
    <time_frame>7 days</time_frame>
    <description>Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class.&#xD;
The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the impact of ATx201 on the treated atopic dermatitis lesion. To determine the systemic exposure of ATx201.</measure>
    <time_frame>4 and 7 days</time_frame>
    <description>Will be assessed by the investigators global assessment (IGA score):&#xD;
0: Clear (no inflammatory signs)&#xD;
Almost clear (just perceptible erythema, just perceptible papulation/infiltration)&#xD;
Mild disease (mild erythema and mild papulation/infiltration)&#xD;
Moderate disease (moderate erythema, moderate papulation/infiltration)&#xD;
Severe disease (severe erythema, severe population/infiltration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment success, defined as a 100-fold reduction in the S. aureus colony count / cm2 of sampled skin lesion</measure>
    <time_frame>4 and 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local dermal tolerability at the sites of application</measure>
    <time_frame>7 days</time_frame>
    <description>Will be assessed using the following dermal assessment score:&#xD;
0 = no evidence of irritation,&#xD;
= minimal erythema, barely perceptible,&#xD;
= definite erythema, readily visible; minimal edema or minimal papular response,&#xD;
= erythema and papule,&#xD;
= definite edema,&#xD;
= erythema, edema, and papule,&#xD;
= vesicular eruption,&#xD;
= strong reaction spreading beyond test site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of new topical formulations of ATx201</measure>
    <time_frame>4 and 15 days</time_frame>
    <description>Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class.&#xD;
The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>ATx201 (2% dermal formulation A) and Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 (2% dermal formulation B) and Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ATx201 (2% dermal formulation C) and Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATx201 dermal formulations 2%</intervention_name>
    <description>Topical application of ATx201 dermal formulations 2%</description>
    <arm_group_label>ATx201 (2% dermal formulation A) and Placebo</arm_group_label>
    <arm_group_label>ATx201 (2% dermal formulation B) and Placebo</arm_group_label>
    <arm_group_label>ATx201 (2% dermal formulation C) and Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General inclusion criteria:&#xD;
&#xD;
          -  Signed and dated informed consent has been obtained&#xD;
&#xD;
          -  Age 18 - 70 years&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Female subjects of childbearing potential must be confirmed not pregnant by a negative&#xD;
             urine pregnancy test prior trial treatment&#xD;
&#xD;
          -  Female subjects of childbearing potential must be willing to use effective&#xD;
             contraceptive at trial entry until completion&#xD;
&#xD;
          -  Male subjects must agree to use adequate contraception for the duration of the trial&#xD;
&#xD;
        Additional inclusion criteria for Phase II of the study:&#xD;
&#xD;
          -  Localized disease (e.g. flexural eczema in a more or less symmetrical distribution on&#xD;
             arms) where two individual lesions each covering an area between 10-200 cm2 and where&#xD;
             each individual lesion has an investigators global assessment score between 1-3.&#xD;
&#xD;
          -  Additional localized lesion of area between 10-200 cm2 and where the individual lesion&#xD;
             has an investigators global assessment score between 1-3.&#xD;
&#xD;
          -  Total localized disease not exceeding 20 % body surface area&#xD;
&#xD;
          -  Colonization of lesions with S.aureus as determined by cultivation&#xD;
&#xD;
        General exclusion criteria&#xD;
&#xD;
          -  Clinically relevant abnormalities in the laboratory testing, vital signs, ECG ( Phase&#xD;
             I only) or physical examination&#xD;
&#xD;
          -  Presence of any skin condition (scars, tattoos,…) that would interfere with the&#xD;
             placement of study medication&#xD;
&#xD;
          -  History of irritation to topical products&#xD;
&#xD;
          -  Current acute or chronic disease unless considered clinically irrelevant by the&#xD;
             Investigator&#xD;
&#xD;
          -  Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory,&#xD;
             gastrointestinal, musculoskeletal, skin (particularly at the site of drug&#xD;
             application), haematological, endocrine or neurological diseases that may interfere&#xD;
             with the aim of the study&#xD;
&#xD;
          -  Positive HIV serology or evidence of active hepatitis&#xD;
&#xD;
          -  Ascertained or presumptive hypersensitivity to the active principle and/or&#xD;
             formulations ingredients of the study drugs (test, reference)&#xD;
&#xD;
          -  History of drug or alcohol abuse (&gt;2 drinks/day, defined according to USDA Dietary&#xD;
             Guidelines 2005)&#xD;
&#xD;
          -  caffeine (&gt;5 cups coffee/tea/day) or tobacco abuse (consumption of 5 or more&#xD;
             cigarettes/week)&#xD;
&#xD;
          -  abnormal or special diet (e.g. vegetarian diet)&#xD;
&#xD;
          -  Blood donations during 6 weeks prior to this study or planned within 6 weeks after the&#xD;
             last blood withdrawal&#xD;
&#xD;
          -  Subject considered unable or unlikely (per Investigator judgment) to comply with&#xD;
             safety and PK profiling requirements (follow-up visits)&#xD;
&#xD;
          -  Subjects who are pregnant (as determined by a positive pregnancy test at the screening&#xD;
             visit) or lactating&#xD;
&#xD;
          -  Participation in another clinical trial with an investigational day within 4 weeks&#xD;
             before screening&#xD;
&#xD;
        Additional exclusion criteria for Phase I of the study:&#xD;
&#xD;
          -  Regular use of medications&#xD;
&#xD;
          -  Use of any dermatological drug therapy on the arms within 14 days before day 1 of this&#xD;
             study&#xD;
&#xD;
        Additional exclusion criteria for Phase II of the study:&#xD;
&#xD;
          -  Treatment with antibiotics (systemic or topical) within the past 3 months and during&#xD;
             the study&#xD;
&#xD;
          -  Treatment with drugs that affect the immune system within the past 3 months and during&#xD;
             the study&#xD;
&#xD;
          -  Treatment with topical steroids and calcineurin inhibitors 1 week before and during&#xD;
             the study treatment period&#xD;
&#xD;
          -  Treatment with systemic steroids within the past month and during the study&#xD;
&#xD;
          -  Use of disinfectant soaps within 1 week before screening and during the study&#xD;
             treatment period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Zeitlinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>General Hospital Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, General Hospital of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</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>Bacterial Infections</mesh_term>
  </condition_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/NCT03009734
org study id: DECOLAD
nct id: NCT03009734
lead sponsor: 
has dmc: Yes
AntibioTx is developping ATx201 as a topical product for treatment of skin infections,
      including infected atopic dermatitis.
Treatment of skin infections, including infected atopic dermatitis, is plagued by inactivity
      of or resistance towards the main topical antibiotics. Accordingly, the infections are either
      not effectively treated or harsher systemic antibiotics with side effects are needed.

      Infections in atopic dermatitis are predominantly caused by Staphylococcus aureus and various
      species of Streptococcus. ATx201 is a potent antibiotic against these and other organisms.
      ATx201 overcomes current resistance problems such as methicillin resistant Staphylococcus
      aureus (MRSA), vancomycin resistant enterococci (VRE) as well as resistance towards all
      topical antibiotics. ATx201 also exhibits an extraordinarily strong ability to delay the
      onset of de novo resistance compared to currently marketed antibiotics.

      The study is a combined Phase I/II study with 36 healthy volunteers and 40 patients.

      The primary objective is to demonstrate the safety and tolerability of new topical
      formulations of ATx201 in healthy volunteers, and in a population of patients with infected
      atopic dermatitis. Efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4
      and 7 days of treatment will be evaluated. In Phase I of the study, three formulations of
      ATx201 including the respective Placebos will be applied to healthy volunteers. One
      formulation will advance into Phase II, where patients will be treated with the respective
      formulation or Placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and tolerability of new topical formulations of ATx201
time frame: 7 days
description: Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class.
The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.
measure: Assessment of the impact of ATx201 on the treated atopic dermatitis lesion. To determine the systemic exposure of ATx201.
time frame: 4 and 7 days
description: Will be assessed by the investigators global assessment (IGA score):
0: Clear (no inflammatory signs)
Almost clear (just perceptible erythema, just perceptible papulation/infiltration)
Mild disease (mild erythema and mild papulation/infiltration)
Moderate disease (moderate erythema, moderate papulation/infiltration)
Severe disease (severe erythema, severe population/infiltration)
measure: Treatment success, defined as a 100-fold reduction in the S. aureus colony count / cm2 of sampled skin lesion
time frame: 4 and 7 days
measure: Local dermal tolerability at the sites of application
time frame: 7 days
description: Will be assessed using the following dermal assessment score:
0 = no evidence of irritation,
= minimal erythema, barely perceptible,
= definite erythema, readily visible; minimal edema or minimal papular response,
= erythema and papule,
= definite edema,
= erythema, edema, and papule,
= vesicular eruption,
= strong reaction spreading beyond test site.
measure: Safety and tolerability of new topical formulations of ATx201
time frame: 4 and 15 days
description: Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class.
The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.
arm group label: ATx201 (2% dermal formulation A) and Placebo
arm group type: Other
arm group label: ATx201 (2% dermal formulation B) and Placebo
arm group type: Other
arm group label: ATx201 (2% dermal formulation C) and Placebo
arm group type: Other
intervention type: Drug
intervention name: ATx201 dermal formulations 2%
description: Topical application of ATx201 dermal formulations 2%
arm group label: ATx201 (2% dermal formulation A) and Placebo
arm group label: ATx201 (2% dermal formulation B) and Placebo
arm group label: ATx201 (2% dermal formulation C) and Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Markus Zeitlinger, MD
role: Principal Investigator
affiliation: General Hospital Vienna
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Bacterial Infections