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Impact of OnabotulinumtoxinA (BOTOX®) on Stress
NCT06778421 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- PROCEDURE Intramuscular injection
- DRUG OnabotulinumtoxinA (Botox®) Injections
- OTHER Sodium Chloride
Study Locations (1)
California
- Center for Advanced Facial Plastic Surgery — Beverly Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-01-20 |
| Est. Completion | 2025-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06778421
The ClinicalTrials.gov registry entry for NCT06778421 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for Advanced Facial Plastic Surgery, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Stress appearing as the primary indexed condition, and to 3 interventions — of which Intramuscular injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06778421 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06778421 about?
NCT06778421 is a clinical study titled "Impact of OnabotulinumtoxinA (BOTOX®) on 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 asso...
What is the current status of trial NCT06778421?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-01-20. Estimated completion is 2025-09.
What conditions does trial NCT06778421 study?
This clinical trial studies the following conditions: Stress, Stress, Physiological, Stress Response, Stress (Psychology), Healthy Adult Female Participants. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06778421?
The interventions under investigation include: Intramuscular injection (PROCEDURE), OnabotulinumtoxinA (Botox®) Injections (DRUG), Sodium Chloride (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06778421?
This trial is sponsored by Center for Advanced Facial Plastic Surgery, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06778421 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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