Impact of OnabotulinumtoxinA (BOTOX®) on Stress

Launched by CENTER FOR ADVANCED FACIAL PLASTIC SURGERY · Jan 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether BOTOX® injections can help reduce stress levels in healthy adult women. Researchers believe that BOTOX® may lower perceived stress, which will be measured using a questionnaire called the Perceived Stress Scale (PSS). The study involves comparing the stress scores of women receiving either BOTOX® or a harmless salt solution (placebo) over a 12-week period, with several clinic visits to monitor progress.

To be eligible for this trial, participants need to be women aged 18 to 65 who can understand and give consent in English and have a certain level of stress as indicated by the PSS. They should also be in good health and not have used any BOTOX® or similar treatments in the past year. Participants can expect to complete questionnaires, receive an injection, and have their vital signs checked during the study visits. It’s important for participants to avoid other cosmetic treatments and certain medications during the trial. This study aims to better understand the potential effects of BOTOX® on stress, which could lead to new treatment options for managing stress in the future.

Gender

FEMALE

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