Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction

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.

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

Study Overview

• Status: Completed
• Conditions: Mood
• Intervention / Treatment: Drug: Botulinum Neurotoxin; Drug: Placebo

Detailed Description

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 Many will want to get treated as soon as stay at home orders are rescinded and clinics are permitted to open back up.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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females between the ages of 18-75
• 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:

• Males and females below the age of 18
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Saline solution (preservative free)
Active Comparator: Botox	Drug: Botulinum Neurotoxin; glabella, forehead lines and/or lateral canthal lines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	1 month

Collaborators and Investigators

• Sponsor: DeNova Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): September 3, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: BTX-PST-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes