Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction
NCT ID: NCT04439825
Last Updated: 2021-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2020-07-20
2020-12-01
Brief Summary
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Detailed Description
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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 Many will want to get treated as soon as stay at home orders are rescinded and clinics are permitted to open back up.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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Botox
Botulinum Neurotoxin
glabella, forehead lines and/or lateral canthal lines
Placebo
Placebo
Saline solution (preservative free)
Interventions
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Botulinum Neurotoxin
glabella, forehead lines and/or lateral canthal lines
Placebo
Saline solution (preservative free)
Eligibility Criteria
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Inclusion Criteria
* Subjects will be non-naive Botox users with a glabellar wrinkle severity score of 2 or 3 who are at least 20 weeks from their last BOTOX Cosmetic treatment
* Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visits.
Exclusion Criteria
* Subjects that received neuromodulator injections to the glabella region in the last 20 weeks
* Subjects who do not meet a 2-3 wrinkle severity score in the glabellar region
* Subjects who have received other invasive or semi invasive cosmetic forehead or glabellar treatments
* Subjects who have had a change in antidepressant or anti- anxiety medication in last 6 weeks
* Subjects with severe depression, bipolar disorder, pregnant,
* Subjects who are pregnant, attempting to get pregnant, or breast feeding
* Subjects with a known allergy or sensitivity to any component of the study ingredients.
* Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
10 Years
75 Years
ALL
Yes
Sponsors
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DeNova Research
OTHER
Responsible Party
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Locations
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DeNova Research
Chicago, Illinois, United States
Countries
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References
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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.
Other Identifiers
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BTX-PST-COVID
Identifier Type: -
Identifier Source: org_study_id
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