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

DeNova Research

Status and phase

Completed

Phase 1

Conditions

Mood

Treatments

Drug: Botulinum Neurotoxin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04439825

BTX-PST-COVID

Details and patient eligibility

About

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

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 Many will want to get treated as soon as stay at home orders are rescinded and clinics are permitted to open back up.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

Enrollment

45 patients

Sex

All

Ages

10 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.