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Stress (Psychology)Phase 1NCT06778421

Impact of OnabotulinumtoxinA (BOTOX®) on Stress

A Phase 1 study testing Intramuscular injection, OnabotulinumtoxinA (Botox®) Injections and Sodium Chloride in people with Stress (Psychology) and Stress, run by Center for Advanced Facial Plastic Surgery at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
What is being tested?
Intramuscular injection, OnabotulinumtoxinA (Botox®) Injections and Sodium Chloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
1 siteUnited States
Study dates
19 Mar 2025to 10 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Participants with history of facial (including periorbital) surgery within the last 12 months
  • Use of neuromodulators in the past ≤ 12 months
  • History or known alcohol and/or illicit drug abuse
  • Participants with psychiatric diagnosis
  • Body Mass Index (BMI) at Screening ≥ 30 kg/m2.
  • Participants with metabolic disorders (e.g., hypothyroidism and hyperparathyroidism)
Show all 17Show fewer
  • 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.
  • 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.
  • Prior use of isotretinoin
  • Active skin disease or infection at or near injection sites
  • Active use of tobacco or nicotine products in any form via any route (e.g. inhalation, ingestion, absorption)
  • Chronic marijuana or tetrahydrocannabinol exposure
  • If the investigators feel that the subject is not a good candidate for the study
  • Females of childbearing potential not using a reliable means of contraception
  • Female subjects must not be breastfeeding
  • Any known previous hypersensitivity reactions to BOTOX®
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Advanced Facial Plastic Surgery

    Beverly Hills, California, 90212-2913

Other trials in United States

About this study

Official title: 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.

Read more

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
Read the 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.

Being tested
Intramuscular injection, OnabotulinumtoxinA (Botox®) Injections, Sodium Chloride
Keywords
stress, BOTOX, PSS, Perceived stress scale, injection, reduction, BTA, facial rejuvenation, aesthetic procedure, psychological impact, clinical trial, facial expressions, stress relief, stress reduction, chemodenervation
Medical subject headings
Stress, Psychological, Fractures, Stress, Facial Expression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intramuscular injectionProcedure or surgery

    Injection performed using method for aesthetic facial rejuvenation procedure with neuromuscular chemodenervation agents

  • OnabotulinumtoxinA (Botox®) InjectionsDrug

    Also called Botulinum Toxin A, BTA

    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.

  • Sodium ChlorideOther

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

Study groups in NCT06778421
Study groupRoleWhat they receive
SalinePlacebo comparatorSterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only
Receives: Procedure: Intramuscular injection; Other: Sodium Chloride
OnabotulinumtoxinA (BOTOX®) injectionExperimentalActive drug reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only
Receives: Procedure: Intramuscular injection; Drug: OnabotulinumtoxinA (Botox®) Injections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Perceived Stress Scale (PSS)

    Chronological decrease at any two points between the first and last completed questionnaire

    Measured: within 12-13 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start19 Mar 2025
  3. Primary completion10 Sep 2025
  4. Study completion10 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06778421
Sponsor's protocol ID
MTIIT-955A
Status last verified
Apr 2026
First submitted
10 Jan 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Charmandari E, Tsigos C, Chrousos G. Endocrinology of the stress response. Annu Rev Physiol. 2005;67:259-84. doi: 10.1146/annurev.physiol.67.040403.120816.

    PubMed 15709959

  • Kubzansky LD, Bordelois P, Jun HJ, Roberts AL, Cerda M, Bluestone N, Koenen KC. The weight of traumatic stress: a prospective study of posttraumatic stress disorder symptoms and weight status in women. JAMA Psychiatry. 2014 Jan;71(1):44-51. doi: 10.1001/jamapsychiatry.2013.2798.

    PubMed 24258147

  • Hori H, Kim Y. Inflammation and post-traumatic stress disorder. Psychiatry Clin Neurosci. 2019 Apr;73(4):143-153. doi: 10.1111/pcn.12820. Epub 2019 Feb 21.

    PubMed 30653780

  • Zhang L, Pan J, Chen W, Jiang J, Huang J. Chronic stress-induced immune dysregulation in cancer: implications for initiation, progression, metastasis, and treatment. Am J Cancer Res. 2020 May 1;10(5):1294-1307. eCollection 2020.

    PubMed 32509380

  • Umamaheswaran S, Dasari SK, Yang P, Lutgendorf SK, Sood AK. Stress, inflammation, and eicosanoids: an emerging perspective. Cancer Metastasis Rev. 2018 Sep;37(2-3):203-211. doi: 10.1007/s10555-018-9741-1.

    PubMed 29948328

  • Bush NR, Savitz J, Coccia M, Jones-Mason K, Adler N, Boyce WT, Laraia B, Epel E. Maternal Stress During Pregnancy Predicts Infant Infectious and Noninfectious Illness. J Pediatr. 2021 Jan;228:117-125.e2. doi: 10.1016/j.jpeds.2020.08.041. Epub 2020 Aug 19.

    PubMed 32827529

  • Glaser R, Kiecolt-Glaser JK. Stress-induced immune dysfunction: implications for health. Nat Rev Immunol. 2005 Mar;5(3):243-51. doi: 10.1038/nri1571.

    PubMed 15738954

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intramuscular injection, OnabotulinumtoxinA (Botox®) Injections and Sodium Chloride in people with Stress (Psychology) and Stress, run by Center for Advanced Facial Plastic Surgery at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Perceived Stress Scale (PSS) (time frame: within 12-13 weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06778421, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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