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Impact of Dysport on PMFF Donor Scar

StatusNot Yet Recruiting
PhasePhase 4
Started2026-09-14
View on ClinicalTrials.gov ↗

Amendment history

2026-08-24
minor
Study Identification, Study Status v1
Start date2026-07-01→2026-09-14
2026-07-16
minor
Original filing
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.
Trial Details
NCT Number NCT07720726
Lead Sponsor Vanderbilt University Medical Center
Collaborators: Galderma R&D
Conditions Skin Cancer Excision Site, Basal Cell Carcinoma, Squamous Cell Carcinoma, Melanoma
Enrollment 50 participants
Start Date 2026-09-14
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-26