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

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Collaborators: Galderma; Galderma R&D
• Treatments: abobotulinumtoxinA; Botulinum Toxins

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