Botox for Stress

Overseen By Principal Investigator

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Center for Advanced Facial Plastic Surgery

Must not be taking: Neuromuscular medications

Disqualifiers: Psychiatric diagnosis, Metabolic disorders, others

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any prescription psychiatric medications or neuromuscular medications that may pose additional risk with BOTOX® treatment.

Is Botox (OnabotulinumtoxinA) generally safe for humans?

Botox (OnabotulinumtoxinA) is generally considered safe for humans, with most side effects being minor, such as bruising or headaches. Serious allergic reactions are rare, and the treatment has a favorable safety profile based on studies for various conditions. ^{1 2 3 4 5}

How is the drug OnabotulinumtoxinA (BOTOX®) unique for treating stress?

OnabotulinumtoxinA (BOTOX®) is unique for treating stress because it is a potent biological toxin that works by blocking nerve signals to muscles, which is different from typical stress treatments like therapy or medication that target brain chemistry. This drug is commonly used for various conditions, including cosmetic and neurological disorders, and its application for stress is novel. ^{6 7 8 9 10}

What data supports the effectiveness of the drug OnabotulinumtoxinA (BOTOX®) for stress?

Research shows that OnabotulinumtoxinA can improve emotional well-being and reduce symptoms of depression, which may indirectly suggest its potential to help with stress. ^{1 3 11 12 13}

Who Is on the Research Team?

Babak Azizzadeh, MD, FACS

Principal Investigator

Center for Advanced Facial Plastic Surgery

Marielle He, MD, MS

Principal Investigator

Center for Advanced Facial Plastic Surgery

Are You a Good Fit for This Trial?

This trial is for generally healthy adult female participants who feel stressed. They must complete basic lab tests before treatment and be available for four clinic visits and one online visit over a 12-week period.

Inclusion Criteria

Subjects capable of giving informed consent in the English language

Perceived Stress Scale (PSS) ≥ 14 at screening

I am a woman aged between 18 and 65.

Exclusion Criteria

Any known previous hypersensitivity reactions to BOTOX®

I am using or recently used medications that may interact with BOTOX®.

I have not had facial surgery in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of either BOTOX® or placebo over a 12-week period

12 weeks

4 visits (in-person), 1 visit (online)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OnabotulinumtoxinA (BOTOX®)

Trial Overview The study is testing if BOTOX® injections can reduce stress levels in women, compared to placebo (salt solution). Participants will receive either BOTOX® or placebo and have their stress measured using the Perceived Stress Scale questionnaire.

How Is the Trial Designed?

Group I: OnabotulinumtoxinA (BOTOX®) injection Experimental Treatment 2 Interventions

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

Group II: Saline Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Center for Advanced Facial Plastic Surgery

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

OnabotulinumtoxinA has been found to be more effective than a placebo in treating major depression, particularly at doses between 20-40 IU, based on a meta-analysis of five randomized controlled trials.

The treatment showed greater efficacy in women and was less effective when patients were taking multiple antidepressants, indicating that individual factors may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of onabotulinumtoxinA in the treatment of unipolar major depression: Systematic review, meta-analysis and meta-regression analyses of double-blind randomised controlled trials. Arnone, D., Galadari, H., Rodgers, CJ., et al.[2022]

OnabotulinumtoxinA (ONA) is generally safe for use in cosmetic procedures, with side effects being rare and typically minor, such as bruising and headaches.

In a reported case, a benign localized skin reaction occurred after ONA injections, which resolved with topical treatment, allowing the patient to safely continue with further injections without any allergic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient localized cutaneous reaction after onabotulinumtoxinA aesthetic injection. Haque, EK., Darwish, YR., Reddick, CS.[2020]

OnabotulinumtoxinA treatment resulted in high patient satisfaction rates, with 97% of patients expressing they would recommend the procedure and 98% willing to undergo retreatment, indicating its efficacy and acceptance.

Patients reported noticeable improvements in facial balance and symmetry, which were also recognized by their significant others, highlighting the treatment's positive impact on both the individual and their close relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Satisfaction and Patients' Family or Significant Other Perceptions After OnabotulinumtoxinA Treatment: A Prospective Cross-Sectional Study. Montes, JR., Ubale, RV.[2019]

A meta-analysis of 1678 participants from multiple studies confirmed that onabotulinumtoxinA is safe and well-tolerated for treating facial lines, with no significant difference in overall adverse event incidence compared to placebo.

The most common treatment-related adverse events were mild to moderate, including eyelid sensory disorder and eyelid ptosis, but these were infrequent and decreased with repeated treatments, indicating a favorable long-term safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. Brin, MF., Boodhoo, TI., Pogoda, JM., et al.[2022]

A novel injection technique for OnabotulinumtoxinA aims to achieve more predictable and reproducible results in eyebrow position and shape, reducing the risk of adverse effects like eyelid and brow ptosis.

OnabotulinumtoxinA works by temporarily paralyzing skeletal muscles to reduce wrinkles, with effects lasting 14-16 weeks, and the new technique enhances safety while maintaining aesthetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel OnabotulinumtoxinA Treatment Technique to Obtain Predictable Outcomes in Eyebrow Position and Shape. Angelo-Khattar, M.[2022]

In a study involving 20 patients with hidradenitis suppurativa, intradermal injections of botulinum toxin type B (BTX-B) significantly improved quality of life, as measured by the Dermatology Life Quality Index, compared to a placebo group.

Patients receiving BTX-B also reported better symptom relief and a reduction in the number of lesions, indicating its efficacy in treating hidradenitis suppurativa, while 55% of participants experienced hyperhidrosis as a comorbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. Grimstad, Ø., Kvammen, BØ., Swartling, C.[2021]

A meta-analysis of 16 trials involving 42,405 participants found that patients receiving Botulinum toxin A (BTX-A) for facial wrinkles experienced significantly more adverse events (AEs) compared to those receiving a placebo, indicating a need for caution in its use.

Specific adverse events associated with BTX-A, particularly in frown wrinkle treatments, included headaches, eyelid ptosis, and heavy eyelids, highlighting the importance of understanding the safety profile and potential side effects for injectors and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Botulinum Toxin Type A in Facial Rejuvenation: A Systematic Review and Meta-Analysis. Jia, Z., Lu, H., Yang, X., et al.[2022]

OnabotulinumtoxinA, approved in 2002 for facial aesthetics, is generally well tolerated and has a range of clinical applications, highlighting its safety and efficacy in cosmetic procedures.

The article also discusses important practical information regarding the handling, storage, and dosing of onabotulinumtoxinA, which is essential for its effective use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of onabotulinumtoxinA (Botox). Lorenc, ZP., Kenkel, JM., Fagien, S., et al.[2018]

Botulinum toxin (BoNT) is a versatile therapeutic agent used across various medical specialties, including ophthalmology, neurology, and dermatology, due to its ability to inhibit abnormal muscle contractions.

The mechanism of action involves chemodenervation at the presynaptic nerve terminal, making BoNT effective for treating a wide range of disorders, although it is important to be aware of potential adverse effects and recommended dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Multispecialty Toxin: A Literature Review of Botulinum Toxin. Bach, K., Simman, R.[2022]

In a pooled analysis of two Phase III studies involving 374 participants, treatment with 50 U of abobotulinumtoxinA (aboBoNT-A) solution resulted in 88% of subjects experiencing none-or-mild glabellar lines one month after treatment, with effects lasting up to 6 months.

The treatment was well tolerated, with mostly mild or moderate nonserious adverse events, and showed high subject satisfaction regarding both appearance and psychological well-being compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. Hilton, S., Kestemont, P., Sattler, G., et al.[2022]

Botulinum neurotoxin (BoNT) is strongly recommended as a treatment for cervical dystonia based on high-quality evidence from seven Class I studies, indicating its efficacy and safety for this condition.

BoNT may also be effective for other movement disorders like blepharospasm and focal upper extremity dystonia, but the evidence is less robust, with recommendations varying from Level A to Level C based on the quality of available studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Simpson, DM., Blitzer, A., Brashear, A., et al.[2022]

In a study of 68 patients receiving over 400 units of onabotulinum toxin A (OnaA) per session, the most common conditions treated were dystonia and spasticity, with a mean duration of benefit lasting about 9 weeks.

Over 70% of patients reported significant improvement in their condition at 6 months, 1 year, and at their last visit, with no serious adverse effects noted, suggesting that higher doses of OnaA may be both safe and effective for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose Botulinum Toxin Therapy: Safety, Benefit, and Endurance of Efficacy. Chiu, SY., Patel, B., Burns, MR., et al.[2021]

Botulinum neurotoxins are effective biologic pharmaceuticals used to treat various chronic conditions, including cervical dystonia and migraines, with a low risk of developing neutralizing antibodies that affect treatment efficacy.

Factors such as the manufacturing process and treatment history can influence the immunogenicity of botulinum neurotoxins, but overall, they show lower levels of clinically detectable antibodies compared to other biologics, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of botulinum toxins. Naumann, M., Boo, LM., Ackerman, AH., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of onabotulinumtoxinA in the treatment of unipolar major depression: Systematic review, meta-analysis and meta-regression analyses of double-blind randomised controlled trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transient localized cutaneous reaction after onabotulinumtoxinA aesthetic injection. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Patient Satisfaction and Patients' Family or Significant Other Perceptions After OnabotulinumtoxinA Treatment: A Prospective Cross-Sectional Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A Novel OnabotulinumtoxinA Treatment Technique to Obtain Predictable Outcomes in Eyebrow Position and Shape. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Events of Botulinum Toxin Type A in Facial Rejuvenation: A Systematic Review and Meta-Analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A review of onabotulinumtoxinA (Botox). [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The Multispecialty Toxin: A Literature Review of Botulinum Toxin. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. [2022]

12. England pubmed.ncbi.nlm.nih.gov

High-dose Botulinum Toxin Therapy: Safety, Benefit, and Endurance of Efficacy. [2021]

13. Austria pubmed.ncbi.nlm.nih.gov

Immunogenicity of botulinum toxins. [2022]