Impact of Dysport on PMFF Donor Scar
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Skin Cancer Excision Site, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
In brief
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.
Key facts
- Study ID
- NCT07720726
- Run by
- Vanderbilt University Medical Center
- People needed
- 50
- Starts
- 2026-07-01
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Documented allergy to Abobotulinumtoxin-A
- Previous hypersensitivity to Abobotulinumtoxin-A
- Hypersensitivity to any botulinum toxin product or excipients
- Previous adverse reaction to any botulinum toxin product or excipients
- Allergy to cow's milk protein
- Infection at proposed injection site
- Previous scar or surgery at proposed injection site
- Inability to follow-up in clinic
- Inability to provide informed consent
- Patient currently on aminoglycoside or other agent interfering with neuromuscular transmission
- Patient on anticholinergic medication
- Pregnancy
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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