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NCT06778421
Pilot Study to Identify the Impact of OnabotulinumtoxinA (BOTOX®) on Patient Perceived Stress.
Phase 1 trial testing Intramuscular injection in Stress (Psychology) in 4 participants. Completed in 10 January 2026.
10 September 2025
Quick facts
| Lead sponsor | Center for Advanced Facial Plastic Surgery |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 19 March 2025 |
| Primary completion | 10 September 2025 |
| Estimated completion | 10 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Intramuscular injection — full drug profile →
- OnabotulinumtoxinA (Botox®) Injections
- Sodium Chloride (Sodium Chloride) — full drug profile →
Conditions studied
- Stress (Psychology) — all drugs for Stress (Psychology) →
- Stress — all drugs for Stress →
- Healthy Adult Female Participants — all drugs for Healthy Adult Female Participants →
- Stress, Psychologic — all drugs for Stress, Psychologic →
Sponsor
Center for Advanced Facial Plastic Surgery
Who can join
Adults 18 to 65, female only, with Stress (Psychology) or Stress. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes in Perceived Stress Scale (PSS)
Time frame: within 12-13 weeks of intervention
Chronological decrease at any two points between the first and last completed questionnaire
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06778421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Stress (Psychology)
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06778421 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Center for Advanced Facial Plastic Surgery
- Last refreshed: 24 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06778421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing