NCT06778421

Impact of OnabotulinumtoxinA (BOTOX®) on Stress

Pilot Study to Identify the Impact of OnabotulinumtoxinA (BOTOX®) on Patient Perceived Stress.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Center for Advanced Facial Plastic Surgery · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Note: The initial phase of this study is limited to those who are assigned female sex at birth, for reasons of treatment dosing only. This study does not have any gender-specific requirements. Future, larger studies, if indicated, will likely be open to all participants. \* Intervention type is masked for both the participant and the treating physician. However, this is subject to change in the case of adverse reactions or events. Please contact study affiliates for additional information.

Conditions

• Stress (Psychology)
• Stress
• Healthy Adult Female Participants
• Stress, Psychologic
• Stress, Psychological Cumulative
• Stress, Physiological
• Stress Response
• Stress Levels
• Stress Perception

Interventions

Type	Name	Description
PROCEDURE	Intramuscular injection	Injection performed using method for aesthetic facial rejuvenation procedure with neuromuscular chemodenervation agents
DRUG	OnabotulinumtoxinA (Botox®) Injections	Injection of 64 units of active drug at a ratio of 4 units to 0.1 mL of sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only \- Abbvie/Allergan drug.
OTHER	Sodium Chloride	Placebo injection of the same volume of preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-07-01
• Completion: 2025-09-01
• First posted: 2025-01-16
• Last updated: 2025-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study