<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/NCT01682200</url>
  </required_header>
  <id_info>
    <org_study_id>PaspaPharma-04</org_study_id>
    <nct_id>NCT01682200</nct_id>
  </id_info>
  <brief_title>Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne</brief_title>
  <official_title>An Open Label Pilot Clinical Trial on the Efficacy and Safety of ProOxy Facial Spray (Topical 15% Oxygen Solution) in the Treatment of Moderate Facial Acne Vulgaris Among Filipino Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medivet Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medivet Pty Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to determine the effects and side effects of ProOxy facial spray in&#xD;
      the treatment of acne.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A study on the effects and side effects of ProOxy facial spray was done. Sixty people were&#xD;
      selected and approved to participate in this study. Pictures of the face (frontal,left side&#xD;
      and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks&#xD;
      intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">March 2010</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>Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.</measure>
    <time_frame>4,8,12 weeks post application of the spray</time_frame>
    <description>Upon acceptance,pictures are taken and acne lesions are identified and counted and after 4,8, and 12 weeks during and after application of ProOxy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>ProOxy, Effects and Side Effects in treating acne</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are instructed to clean the face with ProOxy facial cleanser and then spray on the face wet enough but not dripping twice daily (upon waking up and before bedtime) for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ProOxy</intervention_name>
    <description>Clean the face with ProOxy facial wash before spraying ProOxy on the face enough to wet it twice daily, upon waking up and before bedtime.</description>
    <arm_group_label>ProOxy, Effects and Side Effects in treating acne</arm_group_label>
    <other_name>15% Oxygen solution spray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with acne on their faces only&#xD;
&#xD;
          -  patients who are at least 18 years of age&#xD;
&#xD;
          -  patients who have normal and disease free skin at the dorsal surface of the upper arm.&#xD;
&#xD;
          -  patients who are willing to follow instructions on both the Patch Test Part one and&#xD;
             Part Two procedures and to follow scheduled visits.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  patients with systemic illnesses(such as but not limited to heart disease,&#xD;
             hypertension, diabetes, cancer, liver disease, kidney disease)&#xD;
&#xD;
          -  patients with very dark skin color, Fitzpatrick skin type V-VI, who are prone to&#xD;
             post=inflammatory hyperpigmentation.&#xD;
&#xD;
          -  patients with intake of oral medications including glucocorticoids or any&#xD;
             immuno-suppressants or who have undergone ultraviolet phototherapy for the past 2&#xD;
             weeks prior to the patch test.&#xD;
&#xD;
          -  patients with history of contact dermatitis, dermatographism or anaphylaxis.&#xD;
&#xD;
          -  patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis&#xD;
             and psoriasis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mary Chile General Hospital</name>
      <address>
        <city>Manila</city>
        <state>Metro Manila</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern University Hospital, Dept of Family Medicine</name>
      <address>
        <city>Quezon City</city>
        <state>Metro Manila</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>moderate</keyword>
  <keyword>facial acne</keyword>
  <keyword>acne vulgaris</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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/NCT01682200
org study id: PaspaPharma-04
nct id: NCT01682200
lead sponsor: 
has dmc: No
This study was conducted to determine the effects and side effects of ProOxy facial spray in
      the treatment of acne.
A study on the effects and side effects of ProOxy facial spray was done. Sixty people were
      selected and approved to participate in this study. Pictures of the face (frontal,left side
      and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks
      intervals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.
time frame: 4,8,12 weeks post application of the spray
description: Upon acceptance,pictures are taken and acne lesions are identified and counted and after 4,8, and 12 weeks during and after application of ProOxy.
arm group label: ProOxy, Effects and Side Effects in treating acne
arm group type: Experimental
description: Patients are instructed to clean the face with ProOxy facial cleanser and then spray on the face wet enough but not dripping twice daily (upon waking up and before bedtime) for 3 months.
intervention type: Drug
intervention name: ProOxy
description: Clean the face with ProOxy facial wash before spraying ProOxy on the face enough to wet it twice daily, upon waking up and before bedtime.
arm group label: ProOxy, Effects and Side Effects in treating acne
other name: 15% Oxygen solution spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Acne Vulgaris