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NCT06778421 · ClinicalTrials.gov registry record · Phase 1
Impact of OnabotulinumtoxinA (BOTOX®) on Stress
A Phase 1 study of Stress and Stress, Physiological, sponsored by Center for Advanced Facial Plastic Surgery.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06778421 is a Phase 1 study of Stress and Stress, Physiological that is actively recruiting participants, run by Center for Advanced Facial Plastic Surgery. The registered enrollment target is 20 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06778421, a Phase 1 study of Stress and Stress, Physiological, is actively recruiting participants, sponsored by Center for Advanced Facial Plastic Surgery.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 152 other Stress trials with a reported enrollment target (97% lower). The listed sponsor is Center for Advanced Facial Plastic Surgery, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT06778421 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
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.
What interventions are being tested in trial NCT06778421?
The interventions under investigation include: Intramuscular injection (PROCEDURE), OnabotulinumtoxinA (Botox®) Injections (DRUG), Sodium Chloride (OTHER).
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.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.