Effects of BOTOX® on stress levels in women

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

This study is testing if BOTOX® injections can help reduce stress levels in healthy women compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Center for Advanced Facial Plastic Surgery (Academic / other)
• Locations: 1 site (Beverly Hills, California)
• Trial ID: NCT06778421 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, blinded, randomized proof-of-concept study aimed at evaluating whether OnabotulinumtoxinA (BOTOX®) injections can reduce perceived stress levels in generally healthy adult females. Participants will undergo a series of assessments, including vital signs and BMI measurements, and will complete the Perceived Stress Scale (PSS) questionnaire to measure changes in stress levels over a 12-week period. The study will compare the outcomes of those receiving BOTOX® injections to those receiving a placebo to determine the efficacy of the treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adult females aged 18-65 with a perceived stress score of 14 or higher.

Not a fit: Patients with a history of psychiatric diagnoses or those currently on prescription psychiatric medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel non-pharmacological approach to managing stress in women.

How similar studies have performed: While the use of BOTOX® for cosmetic purposes is well-established, this specific application for stress management is novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Beverly Hills, California

• Center for Advanced Facial Plastic Surgery — Beverly Hills, California, United States (Recruiting)

Study contacts

• Principal investigator: Babak Azizzadeh, MD, FACS — Center for Advanced Facial Plastic Surgery
• Study coordinator: Principal Investigator

Conditions Stress; Healthy Adult Female Participants; Stress, Psychologic; Stress, Psychological Cumulative; Stress, Physiological; Stress Response; Stress Levels; Stress Perception