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NCT03887377 · ClinicalTrials.gov registry record · Phase 2
The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation
A Phase 2 study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT03887377: Completed Phase 2 study, sponsored by Henry Ford Health System.
NCT03887377 is a Phase 2 study that has completed, run by Henry Ford Health System. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887377, a Phase 2 study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
1. Test the ability of botulinum toxin type A, when injected into the surgical incision at the time of surgery, to decrease postoperative scar scores compared to control (normal saline) in a double-blinded randomized control trial. 2. Investigate the mechanism of BTXa effects of scar formation by measuring micro RNA profiles at two time points in the healing process.
Primary Outcome
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0 It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, col
Interventions
- OTHER Normal saline
- DRUG Botulinum Toxins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 2 |
What the finished NCT03887377 record still lists
NCT03887377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03887377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03887377 about?
NCT03887377 is a clinical study titled "The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation". 1. Test the ability of botulinum toxin type A, when injected into the surgical incision at the time of surgery, to decrease postoperative scar scores compared to control (normal saline) in a double-blinded randomized control trial. 2. Investigate the mechanism of BTXa effects of scar formation by me...
What is the current status of trial NCT03887377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2019-06-10. Estimated completion is 2024-12-30.
What interventions are being tested in trial NCT03887377?
The interventions under investigation include: Normal saline (OTHER), Botulinum Toxins (DRUG).
Who is sponsoring clinical trial NCT03887377?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03887377's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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