Botulinum toxin before forehead flap surgery to test scar appearance after nasal skin cancer
Tests abobotulinumtoxin-A on the forehead scar after nose skin cancer reconstruction in adults.
Key facts
- Who runs it
- Vanderbilt University Medical Center
- Where
- Nashville, United StatesSee the site
- Trial code
- Registry title
- Impact of Dysport on PMFF Donor Scar
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 50 people, planned
- Started
- 14 Sept 2026
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Abobotulinumtoxin-A
- Control- Saline injection
- Record updated
- 26 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a forehead flap to rebuild the nose after skin cancer surgery. It tests Dysport injections against saline on the forehead scar.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- A nose defect left after Mohs skin cancer surgery that needs paramedian forehead flap reconstruction. No other facial plastic surgery or skin cancer reconstruction at the same time.
- Earlier treatment
- No previous scar or surgery at the planned injection site.
Main reasons for not taking part
- Allergy or past bad reaction to Abobotulinumtoxin-A or any botulinum toxin product
- Allergy to cow's milk protein
- Infection at the planned injection site
- Taking aminoglycoside, other drugs that affect nerve-muscle signals, or anticholinergic medicine
- Pregnancy
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Adults at least 18 years of age with a post-mohs micrographic surgery nasal defect requiring PMFF reconstruction in the operating room or clinic at our institution
- No other facial plastic surgery procedure or skin cancer reconstruction performed simultaneously
- Lack all the below Exclusion Criteria
Who cannot take part
- Previous hypersensitivity to Abobotulinumtoxin-A
- Previous adverse reaction to any botulinum toxin product or excipients
- Previous scar or surgery at proposed injection site
- Patient currently on aminoglycoside or other agent interfering with neuromuscular transmission
- Patient on anticholinergic medication
- Documented allergy to Abobotulinumtoxin-A
- Hypersensitivity to any botulinum toxin product or excipients
- Allergy to cow's milk protein
- Infection at proposed injection site
- Inability to follow-up in clinic
- Inability to provide informed consent
- Pregnancy
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesContact: Nicole G DeSisto, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dysport ArmTreatment being tested
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.
Treatment: Abobotulinumtoxin-A
- Placebo ArmPlacebo, for comparison
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.
Treatment: Control- Saline injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Impact of Pre-Operative Abobotulinumtoxin-A Injection on Paramedian Forehead Flap Donor Site Scar Aesthetics- A Randomized Controlled Trial
- Plain-language title
- Botulinum toxin before forehead flap surgery to test scar appearance after nasal skin cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 August 2026