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

Phase 1

Completed

• Conditions: Mood
• Interventions: Drug: Placebo; Drug: Botulinum Neurotoxin

• Registration Number: NCT04439825
• Lead Sponsor: DeNova Research

Brief Summary

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

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 Many will want to get treated as soon as stay at home orders are rescinded and clinics are permitted to open back up.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

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-07-20
• Primary Completion: 2020-09-03
• Study Completion: 2020-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Botox	Botulinum Neurotoxin	-

Primary Outcome Measures

Name	Time	Method
Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI.	1 month	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.
Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI.	1 month	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.

Secondary Outcome Measures

Name	Time	Method
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.	1 month	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.

Trial Locations

Locations (1)

DeNova Research; 🇺🇸 Chicago, Illinois, United States