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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

>18 years old

Must not have

History of previous breast surgery with scar affecting inframammary skin

Male Sex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month mark following surgery

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.

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.

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 older than 18 years.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have scars from past breast surgery affecting the skin under my breast.

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I am male.

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I have been diagnosed with Amyotrophic Lateral Sclerosis.

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I have had radiation treatment to my breast.

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I am under 18 years old.

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I have not had botulinum toxin injections in my chest area in the last 6 months.

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I have myasthenia gravis.

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I have Lambert-Eaton Myasthenic Syndrome.

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I do not want to participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month mark following surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 12Eligibility criteria met