Botox for Scar Appearance
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research study is to investigate the effect of pre-operative injections of Dysport (Abobotulinumtoxin-A, commonly known as "Botox") on the cosmetic appearance of and overall satisfaction with study participant's forehead scar following paramedian forehead flap reconstruction for a nasal skin cancer defect. Participating in this research involves study participants being randomly placed in one of two treatment groups. The first treatment group will have "Botox" injected at the site of the planned forehead incision once the study participant is in the operating room and asleep, but prior to the start of the operation. The second treatment group will have normal saline injected at the site of the planned forehead incision to act as a control group. The study participant will then undergo paramedian forehead flap reconstruction of the nasal defect in the standard fashion by a facial plastic and reconstructive surgeon. At all post-operative appointments, photographs will be taken of the study participant's forehead scar, and the study participant will be asked to complete two short surveys. These two surveys will take approximately 5 minutes total to complete. Study participants may choose to participate in this research study so that the investigators may learn more about the cosmetic benefit of "Botox" when it comes to scar prevention which could potentially help future patients having the same surgery.
Who Is on the Research Team?
Shiayin F Yang, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) who need forehead flap surgery to repair a nasal skin cancer defect after Mohs surgery. Participants can't join if they're pregnant, allergic to Botox or cow's milk protein, have an infection at the injection site, had previous scars or surgeries there, take certain medications, or can't attend follow-ups.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Injection
Participants receive an injection of Dysport or saline to the Frontalis muscle prior to paramedian forehead flap reconstruction
Surgery and Immediate Post-operative Care
Participants undergo paramedian forehead flap reconstruction and immediate post-operative care
Follow-up
Participants are monitored for scar appearance and satisfaction at regular intervals post-operatively
What Are the Treatments Tested in This Trial?
Interventions
- Abobotulinumtoxin-A (Dysport)
Trial Overview
The study compares pre-surgery injections of Dysport ('Botox') versus saline (salt water) into the forehead before reconstructive nose surgery. Patients are randomly assigned to one group and their scar appearance and satisfaction are tracked with photos and surveys after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants in the treatment arm will receive an injection of a total of 30 units of Dysport (Abobotulinumtoxin-A) to the Frontalis muscle on each side of the planned incision prior to paramedian forehead flap reconstruction of a nasal Mohs defect. Injection will occur in the operating room following anesthesia induction but prior to surgical prepping and draping.
Participants in the control arm will receive an injection of a total of 30 units of saline to the Frontalis muscle on each side of the planned incision prior to paramedian forehead flap reconstruction of a nasal Mohs defect. Injection will occur in the operating room following anesthesia induction but prior to surgical prepping and draping.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Galderma R&D
Industry Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD
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