NCT07720726Not yet recruitingPhase 4
Impact of Dysport on PMFF Donor Scar
The Impact of Pre-Operative Abobotulinumtoxin-A Injection on Paramedian Forehead Flap Donor Site Scar Aesthetics- A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- 14 Sept 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Melanoma
- NCT number
- NCT07720726
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 14 Sept 2026 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Documented allergy to Abobotulinumtoxin-A
- Hypersensitivity to any botulinum toxin product or excipients
- Allergy to cow's milk protein
- Infection at proposed injection site
Other
- Inability to follow-up in clinic
- Inability to provide informed consent
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.