The purpose of this prospective single-center, blinded\*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period.
Comparison of the placebo- and BOTOX-treated participant scores will either support or disprove the study hypothesis.
Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment.
The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve:
* vital signs and Body Mass Index (BMI) measurements
* basic/interval history and physical
* 2 Perceived Stress Scale (PSS) questionnaires
* injection of 64 units of either BOTOX or sterile salt solution
* stay for 60-minutes after treatment for monitoring and to complete study tasks
Phase:
PHASE1
Details
Lead Sponsor:
Center for Advanced Facial Plastic Surgery
Treatments:
Botulinum Toxins, Type A Injections Injections, Intramuscular Sodium Chloride