Impact of OnabotulinumtoxinA (BOTOX®) on Stress

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

Conditions

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

Interventions

OTHER

Sodium Chloride

Placebo injection of the same volume of preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only.

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.

Sponsors & Collaborators

• Center for Advanced Facial Plastic Surgery

  lead OTHER

Principal Investigators

• Babak Azizzadeh, MD, FACS · Center for Advanced Facial Plastic Surgery

• Marielle He, MD, MS · Center for Advanced Facial Plastic Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-19

Primary Completion

2025-09-10

Completion

2026-01-10

FDA Drug

Yes

Countries

• United States

Study Locations