<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/NCT04439825</url>
  </required_header>
  <id_info>
    <org_study_id>BTX-PST-COVID</org_study_id>
    <nct_id>NCT04439825</nct_id>
  </id_info>
  <brief_title>Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction</brief_title>
  <official_title>Randomized Controlled Single Blind Cross Over Trial Evaluating the Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction in a Post Covid Period.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DeNova Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DeNova Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Botox treatment into the upper one third of the face (glabella, forehead lines and/or lateral&#xD;
      canthal lines) to analyze mood and self -appearance satisfaction in a Post Covid period on&#xD;
      non-naïve Botox patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A historical period that will never happen again provides us a unique opportunity to evaluate&#xD;
      the impact Botox Cosmetic has on the mood and self appearance satisfaction after a societal&#xD;
      crisis such as the COVID19 pandemic.&#xD;
&#xD;
      Many regular users of Botox Cosmetic will have exceeded their normal treatment interval and&#xD;
      their glabellar wrinkles will likely have returned to baseline. Many will want to get treated&#xD;
      as soon as stay at home orders are rescinded and clinics are permitted to open back up. It&#xD;
      would not be surprising that these patients also are experiencing a decrease in their mood&#xD;
      secondary to weeks of social isolating and distancing. Many can expect to have a rebound&#xD;
      elevation in their happiness and overall mood following the modified return to normalcy.&#xD;
&#xD;
      Botox Cosmetic has been studied as a mood elevating drug by reducing the animation of a&#xD;
      glabellar furrow via the facial feedback mechanism hypothesis. This has been shown in&#xD;
      patients who are not diagnosed with a major depressive disorder. Following a natural&#xD;
      disaster, does the administration of Botox Cosmetic, in patients who are frequent Botox&#xD;
      Cosmetic users, synergistically amplify the elevation in mood beyond what would be achieved&#xD;
      had they not had their Botox Cosmetic treatment. Perhaps regular Botox Cosmetic users have a&#xD;
      secondary gain desire for Botox Cosmetic beyond wrinkle reduction but also as a mood&#xD;
      elevator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 3, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI.</measure>
    <time_frame>1 month</time_frame>
    <description>Treatment with Botox into the glabellar furrows increase the self- satisfaction with appearance once optimal correction is achieved beyond baseline in non -naïve users as compared to a control group and to themselves.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI.</measure>
    <time_frame>1 month</time_frame>
    <description>Treatment with Botox into the glabellar furrows increase the happiness levels once optimal correction is achieved beyond baseline in non -naïve users as compared to a control group and to themselves.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the Glabellar Wrinkle Severity Scores before treatment. The onset of effect and maximum efficacy compared to previous BOTOX Cosmetic injections will also be assessed by questionnaires.</measure>
    <time_frame>1 month</time_frame>
    <description>Do non-naïve patients of Botox who have a baseline wrinkle severity score of 2 or 3 on the severity scale following an extended interval since last treatment of greater than 20 weeks achieve a two-point improvement 2 to 4 weeks after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Mood</condition>
  <arm_group>
    <arm_group_label>Botox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Neurotoxin</intervention_name>
    <description>glabella, forehead lines and/or lateral canthal lines</description>
    <arm_group_label>Botox</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline solution (preservative free)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females between the ages of 18-75&#xD;
&#xD;
          -  Subjects will be non-naive Botox users with a glabellar wrinkle severity score of 2 or&#xD;
             3 who are at least 20 weeks from their last BOTOX Cosmetic treatment&#xD;
&#xD;
          -  Subjects that understand the purpose and aspects of the study, freely sign the consent&#xD;
             and complete the required treatment and follow up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males and females below the age of 18&#xD;
&#xD;
          -  Subjects that received neuromodulator injections to the glabella region in the last 20&#xD;
             weeks&#xD;
&#xD;
          -  Subjects who do not meet a 2-3 wrinkle severity score in the glabellar region&#xD;
&#xD;
          -  Subjects who have received other invasive or semi invasive cosmetic forehead or&#xD;
             glabellar treatments&#xD;
&#xD;
          -  Subjects who have had a change in antidepressant or anti- anxiety medication in last 6&#xD;
             weeks&#xD;
&#xD;
          -  Subjects with severe depression, bipolar disorder, pregnant,&#xD;
&#xD;
          -  Subjects who are pregnant, attempting to get pregnant, or breast feeding&#xD;
&#xD;
          -  Subjects with a known allergy or sensitivity to any component of the study&#xD;
             ingredients.&#xD;
&#xD;
          -  Subjects that do not understand the purpose and aspects of the study, do not sign the&#xD;
             consent and do not complete the required treatment and follow up visit will also be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DeNova Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Dayan SH. Mind, Mood, and Aesthetics. Aesthet Surg J. 2015 Aug;35(6):759-61. doi: 10.1093/asj/sjv032. Epub 2015 Jun 4. No abstract available.</citation>
    <PMID>26044342</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 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>Botulinum Toxins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 16, 2021</submitted>
    <returned>April 1, 2021</returned>
    <submitted>October 11, 2021</submitted>
    <returned>October 12, 2021</returned>
    <submitted>December 1, 2022</submitted>
  </pending_results>
  <!-- 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/NCT04439825
org study id: BTX-PST-COVID
nct id: NCT04439825
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Botox treatment into the upper one third of the face (glabella, forehead lines and/or lateral
      canthal lines) to analyze mood and self -appearance satisfaction in a Post Covid period on
      non-naïve Botox patients
A historical period that will never happen again provides us a unique opportunity to evaluate
      the impact Botox Cosmetic has on the mood and self appearance satisfaction after a societal
      crisis such as the COVID19 pandemic.

      Many regular users of Botox Cosmetic will have exceeded their normal treatment interval and
      their glabellar wrinkles will likely have returned to baseline. Many will want to get treated
      as soon as stay at home orders are rescinded and clinics are permitted to open back up. It
      would not be surprising that these patients also are experiencing a decrease in their mood
      secondary to weeks of social isolating and distancing. Many can expect to have a rebound
      elevation in their happiness and overall mood following the modified return to normalcy.

      Botox Cosmetic has been studied as a mood elevating drug by reducing the animation of a
      glabellar furrow via the facial feedback mechanism hypothesis. This has been shown in
      patients who are not diagnosed with a major depressive disorder. Following a natural
      disaster, does the administration of Botox Cosmetic, in patients who are frequent Botox
      Cosmetic users, synergistically amplify the elevation in mood beyond what would be achieved
      had they not had their Botox Cosmetic treatment. Perhaps regular Botox Cosmetic users have a
      secondary gain desire for Botox Cosmetic beyond wrinkle reduction but also as a mood
      elevator.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI.
time frame: 1 month
description: Treatment with Botox into the glabellar furrows increase the self- satisfaction with appearance once optimal correction is achieved beyond baseline in non -naïve users as compared to a control group and to themselves.
measure: Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI.
time frame: 1 month
description: Treatment with Botox into the glabellar furrows increase the happiness levels once optimal correction is achieved beyond baseline in non -naïve users as compared to a control group and to themselves.
measure: Measurement of the Glabellar Wrinkle Severity Scores before treatment. The onset of effect and maximum efficacy compared to previous BOTOX Cosmetic injections will also be assessed by questionnaires.
time frame: 1 month
description: Do non-naïve patients of Botox who have a baseline wrinkle severity score of 2 or 3 on the severity scale following an extended interval since last treatment of greater than 20 weeks achieve a two-point improvement 2 to 4 weeks after treatment.
arm group label: Botox
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Botulinum Neurotoxin
description: glabella, forehead lines and/or lateral canthal lines
arm group label: Botox
intervention type: Drug
intervention name: Placebo
description: Saline solution (preservative free)
arm group label: Placebo
criteria: 
gender: All
minimum age: 10 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Dayan SH. Mind, Mood, and Aesthetics. Aesthet Surg J. 2015 Aug;35(6):759-61. doi: 10.1093/asj/sjv032. Epub 2015 Jun 4. No abstract available.
PMID: 26044342
responsible party type: Sponsor
mesh term: Botulinum Toxins
sharing ipd: No
submitted: March 16, 2021
returned: April 1, 2021
submitted: October 11, 2021
returned: October 12, 2021
submitted: December 1, 2022