Impact of OnabotulinumtoxinA (BOTOX®) on Stress

NCT06778421 | Completed Phase 1 FDA Drug

• 1 other identifier: MTIIT-955A
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Changes in Perceived Stress Scale (PSS)

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

  within 12-13 weeks of intervention

Study Arms (2)

Saline

PLACEBO COMPARATOR

Sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only

Procedure: Intramuscular injection; Other: Sodium Chloride

OnabotulinumtoxinA (BOTOX®) injection

EXPERIMENTAL

Active drug reconstituted with sterile, preservative-free 0.9% Sodium Chloride Injection, United States Pharmacopeia (USP) Only

Procedure: Intramuscular injection; Drug: OnabotulinumtoxinA (Botox®) Injections

Interventions

Intramuscular injection PROCEDURE

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

OnabotulinumtoxinA (BOTOX®) injection; Saline

OnabotulinumtoxinA (Botox®) Injections DRUG

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.

Also known as: Botulinum Toxin A, BTA

OnabotulinumtoxinA (BOTOX®) injection

Sodium Chloride OTHER

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

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Center for Advanced Facial Plastic Surgery: lead

Study Sites (1)

Center for Advanced Facial Plastic Surgery

Beverly Hills, California, 90212-2913, United States

Location

Related Publications (7)

• 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.

  PMID: 15709959 BACKGROUND

• Kubzansky LD, Bordelois P, Jun HJ, et al. The weight of traumatic stress: a prospective study of posttraumatic stress disorder symptoms and weight status in women. JAMA Psychiatry. 2014;71(1):4451. doi:10.1001/jamapsychiatry.2013.2798

  BACKGROUND

• 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.

  PMID: 30653780 BACKGROUND

• 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.

  PMID: 32509380 BACKGROUND

• 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.

  PMID: 29948328 BACKGROUND

• 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.

  PMID: 32827529 BACKGROUND

• 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.

  PMID: 15738954 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Fractures, Stress; Facial Expression

Interventions

Injections, Intramuscular; Botulinum Toxins, Type A; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Fractures, Bone; Wounds and Injuries; Nonverbal Communication; Communication

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Babak Azizzadeh, MD, FACS

  Center for Advanced Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Marielle He, MD, MS

  Center for Advanced Facial Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: March 19, 2025
• Primary Completion: September 10, 2025
• Study Completion: January 10, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: January 2027-Indefinite
• Access Criteria: Email clinicaltrial@facialplasticbh.com

Locations

US (1)