Botox for Scar Appearance

NG
Overseen ByNicole G DeSisto, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Vanderbilt University Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial

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?

SF

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

I am 18 or older and need nasal reconstruction after Mohs surgery.
Lack all the listed Exclusion Criteria
I am not having any other facial plastic surgery or skin cancer reconstruction at the same time.

Exclusion Criteria

Documented allergy to Abobotulinumtoxin-A
I have an infection where the injection will be given.
Allergy to cow's milk protein
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Injection

Participants receive an injection of Dysport or saline to the Frontalis muscle prior to paramedian forehead flap reconstruction

1 day
1 visit (in-person)

Surgery and Immediate Post-operative Care

Participants undergo paramedian forehead flap reconstruction and immediate post-operative care

1 week
1 visit (in-person)

Follow-up

Participants are monitored for scar appearance and satisfaction at regular intervals post-operatively

1 year
5 visits (in-person)

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

Group I: Dysport ArmExperimental Treatment1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Galderma R&D

Industry Sponsor

Trials
303
Recruited
60,700+
Flemming Ørnskov profile image

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini profile image

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD