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Neurotoxin

Botulinum Toxin for Scarring

Phase 2 & 3
Waitlist Available
Led By David Ozog, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing breast reduction surgery
Willing to participate in study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month mark following surgery
Awards & highlights

Study Summary

This trial will test whether botulinum toxin type A can reduce the appearance of scars when injected into the wound at the time of surgery. The mechanism of action will be investigated by measuring micro RNA profiles at two different points in the healing process.

Who is the study for?
This trial is for women over 18 who are having breast reduction surgery and can attend follow-up appointments for up to 6 months. It's not suitable for those allergic to botulinum toxin, pregnant or breastfeeding, with a history of certain scars or neuromuscular disorders, previous chest injections of botulinum toxin within the last six months, or past breast surgery affecting certain skin areas.Check my eligibility
What is being tested?
The study tests if injecting botulinum toxin into surgical incisions at the time of breast reduction surgery reduces scar formation better than a saline control. It's a double-blinded trial where neither participants nor researchers know who receives which treatment until after results are collected.See study design
What are the potential side effects?
Botulinum toxins may cause localized pain, swelling at the injection site, muscle weakness near the treated area, headache, or flu-like symptoms. Rarely it could lead to more serious effects like problems swallowing, speaking or breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am planning to have breast reduction surgery.
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I am willing to participate in the study.
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I am older than 18 years.
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I am female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month mark following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month mark following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Breast receiving botulinum toxinExperimental Treatment1 Intervention
Following reconstruction one horizontal incisional wound will be selected to receive a series of botulinum toxin injections along the wound. Injection abobotulinum toxin at time of surgery, single injection time with 30 gauge needle superficially, dosage determined by length of scar 5-15U per cm
Group II: Breast receiving placeboPlacebo Group1 Intervention
The other breast will be injected with bacteriostatic normal saline in a similar fashion to the other breast. The injector will be blinded to the contents of the syringe.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,977 Total Patients Enrolled
Galderma R&DIndustry Sponsor
298 Previous Clinical Trials
60,296 Total Patients Enrolled
David Ozog, MDPrincipal InvestigatorHenry Ford Hospital
4 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Botulinum Toxin (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT03887377 — Phase 2 & 3
Hypertrophic Scar Research Study Groups: Breast receiving botulinum toxin, Breast receiving placebo
Hypertrophic Scar Clinical Trial 2023: Botulinum Toxin Highlights & Side Effects. Trial Name: NCT03887377 — Phase 2 & 3
Botulinum Toxin (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03887377 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific experiments have used Botulinum Toxins?

"There are currently sixty-eight different clinical trials studying botulinum toxins. Of these, twenty-two are in Phase III. The majority of research locations for this treatment are situated in Farmington Hills, Michigan; however, there are 761 total sites running studies on botulinum toxins globally."

Answered by AI

How many people are included in the research project?

"Unfortunately, this research is no longer enrolling patients. The trial was advertised from June 10th, 2019 to July 20th, 2022. If you are still seeking studies, there are 65 active trials for scarring and 68 for Botulinum Toxins currently looking for participants."

Answered by AI

Are we still looking for volunteers for this experiment?

"No, the study detailed on clinicaltrials.gov is no longer recruiting patients for participation. Having first been posted on June 10th 2019, with the most recent update being July 20th 2022, this research has now closed to new applicants. There are, however, many other trials (133 in total) that have active recruitment statuses."

Answered by AI

Might I be able to join this experiment?

"We are looking for 22 participants, all adults aged 18 to 65, who have some degree of scarring. Additionally, these patients must also be scheduled for breast reduction surgery and not meet any other exclusion criteria."

Answered by AI

Can young people participate in this research project?

"According to the rules for this trial, anyone 18-65 years old may participate."

Answered by AI

For what reasons are people usually given Botulinum Toxins?

"Botulinum Toxins are most commonly used to treat urinary incontinence, but they can also help alleviate symptoms for other conditions like spinal cord injury, botulism, and overactive bladder syndrome."

Answered by AI
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~3 spots leftby Dec 2024