Status:
COMPLETED
Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction
Lead Sponsor:
DeNova Research
Conditions:
Mood
Eligibility:
All Genders
10-75 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04439825
Start Date
July 20 2020
End Date
December 1 2020
Last Update
March 15 2021
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611