CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 enrolled
Drug / intervention
Botulinum Toxins +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03887377
NCT03887377Phase 3Completed
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The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation: A Prospective, Controlled, Randomized, Double-blinded Study

Henry Ford Health System·interventional·Posted Mar 25, 2019·Updated Jun 15, 2025

In Brief

A Phase 3 clinical trial evaluating Botulinum Toxins and Normal saline for Scar and 2 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScar, Hypertrophic Scar, Mammary Disorder
CountriesUnited States
CollaboratorsGalderma R&D

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartJun 10, 2019
Primary CompletionDec 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 7.3 years ago

Interventions

Botulinum Toxinsdrug

We will be comparing botulinum toxin following breast reduction surgery to placebo injection. We will then compare photos of each breast reduction scar at set intervals following surgery.

Normal salineother

Normal saline will serve as the placebo control on the contralateral breast