Impact of OnabotulinumtoxinA (BOTOX®) on Stress

April 24, 2026 updated by: Center for Advanced Facial Plastic Surgery

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90212-2913
        • Center for Advanced Facial Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects capable of giving informed consent in the English language
  2. Females 18-65 years of age
  3. Perceived Stress Scale (PSS) ≥ 14 at screening.
  4. Participants who have been toxin-naive for ≥1 year (i.e. onabotulinumtoxinA (BOTOX®), alternatives, or its derivatives)
  5. Female subjects willing to minimize the risk of inducing pregnancy for the duration of clinical study
  6. Subjects in good physical and mental health and not on any prescription psychiatric medications
  7. Subjects willing to not undergo any other aesthetic or skin treatments for the duration of the study

Exclusion Criteria:

  1. Participants with history of facial (including periorbital) surgery within the last 12 months
  2. Use of neuromodulators in the past ≤ 12 months
  3. History or known alcohol and/or illicit drug abuse
  4. Participants with psychiatric diagnosis
  5. Body Mass Index (BMI) at Screening ≥ 30 kg/m2.
  6. Participants with metabolic disorders (e.g., hypothyroidism and hyperparathyroidism)
  7. Undiagnosed, unstable, or preexisting conditions that in the opinion of the investigators, would interfere with the course and conduct of the study. These include but are not limited to inflammatory disorders, diseases that affect muscles and/or nerves such as myasthenia gravis and Lambert-Eaton syndrome, high blood pressure, heart disease, and/or stroke that could result in a life-threatening response when treated with BOTOX® or placebo.
  8. Participant has any laboratory abnormality (found on screening) that, in the opinion of the investigators, is clinically significant, has not resolved at baseline and could jeopardize or would compromise the participant's ability to participate in this study.
  9. Prior use of isotretinoin
  10. Active skin disease or infection at or near injection sites
  11. Active use of tobacco or nicotine products in any form via any route (e.g. inhalation, ingestion, absorption)
  12. Chronic marijuana or tetrahydrocannabinol exposure
  13. If the investigators feel that the subject is not a good candidate for the study
  14. Females of childbearing potential not using a reliable means of contraception
  15. Female subjects must not be breastfeeding
  16. Any known previous hypersensitivity reactions to BOTOX®
  17. Current or recent (within therapeutic window) use of neuromuscular medications that may pose additional risk with treatment with BOTOX®, such as but not limited to amino-glycosides and anticholinergic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Sterile, 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
Other: Sodium Chloride
Placebo injection of the same volume of preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only.
Experimental: OnabotulinumtoxinA (BOTOX®) injection
Active drug reconstituted with sterile, 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.

Other Names:
  • BTA
  • Botulinum Toxin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Perceived Stress Scale (PSS)
Time Frame: within 12-13 weeks of intervention
Chronological decrease at any two points between the first and last completed questionnaire
within 12-13 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Advanced Facial Plastic Surgery

Investigators

  • Principal Investigator: Babak Azizzadeh, MD, FACS, Center for Advanced Facial Plastic Surgery
  • Principal Investigator: Marielle He, MD, MS, Center for Advanced Facial Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2025

Primary Completion (Actual)

September 10, 2025

Study Completion (Actual)

January 10, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 11, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTIIT-955A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

January 2027-Indefinite

IPD Sharing Access Criteria

Email clinicaltrial@facialplasticbh.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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