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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: Recruiting Phase 1 study of Stress and Stress, Physiological, sponsored by Center for Advanced Facial Plastic Surgery.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Chronological decrease at any two points between the first and last completed questionnaire

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

FieldValue
Enrollment Target 20 participants
Start Date 2025-01-20
Est. Completion 2025-09
Phase Phase 1

What NCT06778421 shows while recruiting

NCT06778421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (97% lower).

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 a single indexed study location in 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.

Similar trials for Stress

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06778421's enrollment target sits among peer trials

20 142nd of 152 higher than 8 of 152 other Stress trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06778421, the US trial registry maintained by the National Library of Medicine. NCT06778421 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.