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

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ClinicalTrials.gov Identifier: NCT03887377
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Galderma
Information provided by (Responsible Party):
David M. Ozog, Henry Ford Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Scar Hypertrophic Scar Mammary Disorder Drug: Botulinum Toxins Drug: Normal saline Phase 2 Phase 3

Detailed Description:

Breast reduction mammoplasty is an increasingly popular procedure in this country due to not only the perceived cosmetic benefit of the procedure but additionally the improvement in musculoskeletal pain, headaches, sleeping difficulties, breathing, depression, self-esteem, and eating disorders. Despite these benefits, outcome satisfaction the typical inverted-T scar of the Wise pattern reduction has been limited by the resulting scar formation on the breast tissue. One study demonstrated that although 86% of patients were highly satisfied with their surgery, 65% were dissatisfied with their scars, with the majority of those dissatisfied , 65%, being bothered by the horizontal component of the scar. To address cosmetic outcomes of the procedure multiple techniques have been purposed in the literature including: superior pedicle technique, vertical mammoplasty, and circum-areolar breast reduction. By selectively injecting the horizontal component of the mammoplasty scar our analysis should be independent of surgeon surgical approach if it should include a vertical incisional scar. Aesthetic results of breast mammoplasty have also been attributed to analysis of breast meridian length, modifying areolar shape and most importantly tailoring or the medial inframammary crease. Tension across the inframammary crease requires appropriate shaping in order to reduce scar hypertrophy.

Mechanical stress from wound tension has been thought to play a major role in hypertrophic scar development. Cellular and biochemical studies have demonstrated that excessive forces on tissues are tightly linked to changes in the extracellular matrix such as the induction of wound fibrosis and inhibition of fibroblast apoptosis. Recently, botulinum toxin type A has been reported as a treatment agent to counteract these effects. Although its precise mechanism is not yet completely understood, botulinum toxin type A is thought to promote apoptosis of fibroblasts derived from hypertrophic scars, leading to reduced tensile forces. In an in vivo study, human hypertrophic scars treated with botulinum toxin type A had significantly reduced fibroblast proliferation compared to a control, and had synergistic effects with intralesional steroid injections, which is a commonly used treatment but with multiple adverse effects.

Botulinum toxin type A is a potent neurotoxin used in a wide scope of clinical settings, and has been injected for cosmetic purposes for more than two decades. Its clinical use specifically for hypertrophic scars, including those of the face, has recently been demonstrated. Furthermore, a randomized double-blinded split scar study has demonstrated the safety and efficacy of botulinum toxin type A injection into thyroidectomy scars for scar prevention. Although a well-controlled and designed study, its weaknesses include the difficult applicability of the Korean population to that of the United States, the relatively small number of patients included in the trial, the injection of botulinum toxin type A post-surgery instead of at the time of surgery (as the latter is often reported in other studies and is thought to be more beneficial). This protocol is designed to test the ability of botulinum toxin type A to improve post-surgical breast scarring in a randomized, double-blinded, controlled clinical trial at Henry Ford Hospital. It expands upon previous studies that have already demonstrated its safety and good tolerance profile, and will combine the expertise of the Dermatology department and Plastic surgeons. We will study breast reduction scars, as this will allow patients to serve as their own control group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Each patient will serve as their own control as one breast incision will be injected with botulinum toxin type A while the other will receive placebo.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The injector, patient, and outcome assessor will be blinded to the treatment side and placebo side of injection.
Primary Purpose: Prevention
Official Title: The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation: A Prospective, Controlled, Randomized, Double-blinded Study
Estimated Study Start Date : April 29, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breast receiving botulinum toxin

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

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 Names:
  • Dysport
  • BTXa
  • abobotulinumtoxinA

Placebo Comparator: Breast receiving placebo
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.
Drug: Normal saline
Normal saline will serve as the placebo control on the contralateral breast




Primary Outcome Measures :
  1. Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS) [ Time Frame: Photos will be reviewed at the 1 week follow surgery ]

    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, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.


  2. Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS) [ Time Frame: 4-8 weeks following surgery ]

    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, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.

    These scores will be compared to the 1 week time point.


  3. Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS) [ Time Frame: 6 month mark following surgery ]

    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, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.

    These scores will be compared to the 1 week and the 4-8 weeks time point.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Undergoing breast reduction surgery
  2. Does not meet any exclusion criteria
  3. Female
  4. >18 years old
  5. Willing to participate in study

Exclusion Criteria:

  1. Allergy to botulinum toxin
  2. Currently pregnant or breast feeding
  3. Myasthenia gravis
  4. Lambert-Eaton Myasthenic Syndrome
  5. Amyopathic Lateral Sclerosis
  6. Previous injection of botulinum toxin in the chest area within 6 months prior to enrollment
  7. History of keloid or hypertrophic scar
  8. History of previous breast surgery with scar affecting inframammary skin
  9. Male Sex
  10. Refusal to participate in the study
  11. Unable to make follow up appointments up to 6 months
  12. Less than 18 years of age
  13. History of radiation to the breast

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887377


Contacts
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Contact: Jennifer Creasor, RN 313-676-9672 Jcreaso2@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Galderma
Investigators
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Principal Investigator: David Ozog, MD Henry Ford Hospital

Publications of Results:

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Responsible Party: David M. Ozog, Chair of Department of Dermatology, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03887377     History of Changes
Other Study ID Numbers: 12373
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be a publication based on the results of the study. We will not be sharing individual participant data outside of our facility. All data will be kept on the secure drive at Henry Ford Health Systems.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David M. Ozog, Henry Ford Health System:
macromastia
botulinum toxin
scar prevention
scar formation
Additional relevant MeSH terms:
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Cicatrix
Cicatrix, Hypertrophic
Fibrosis
Pathologic Processes
Botulinum Toxins
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs