MedTrace Logo

The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation

NCT03887377 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-06-15

No results posted yet for this 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.

Conditions

  • Scar
  • Hypertrophic Scar
  • Mammary Disorder

Interventions

DRUG

Botulinum Toxins

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.

OTHER

Normal saline

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

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • David Ozog, MD · Henry Ford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887377 on ClinicalTrials.gov