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as soon as stay at home orders are rescinded and clinics are permitted to open back up.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.
Drug: Botulinum Neurotoxin
glabella, forehead lines and/or lateral canthal lines
Drug: Placebo
Saline solution (preservative free)
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.
DeNova Research
Chicago, Illinois, United States