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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 Many will want to get treated as soon as stay at home orders are rescinded and clinics are permitted to open back up.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Neurotoxin | Drug | glabella, forehead lines and/or lateral canthal lines |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI. | 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. | 1 month |
| Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI. | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26044342 | Result | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 16, 2021 | |
| Reset | Apr 1, 2021 | |
| Release | Oct 11, 2021 | |
| Reset | Oct 12, 2021 | |
| Release | Dec 1, 2022 | |
| Reset | Sep 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 16, 2021 | Apr 1, 2021 | |||
| Oct 11, 2021 |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Placebo |
| Drug |
Saline solution (preservative free) |
|
| 1 month |
| Oct 12, 2021 |
| Dec 1, 2022 | Sep 21, 2023 |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |