Impact of Dysport on PMFF Donor Scar

NCT07720726 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 202132026080237
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer Excision Site; Squamous Cell Carcinoma; Melanoma; Basal Cell Carcinoma

Keywords

Mohs Micrographic Surgery; Nasal Defect; Paramedian Forehead Flap; Wound Healing

Outcome Measures

Primary Outcomes (4)

• Patient Observer Scar Assessment Scale (POSAS)

  Patient satisfaction with the appearance of the forehead donor site will be assessed at pre-determined time intervals using the Patient Observer Scar Assessment Scale (POSAS). This is a 7 question scale with all questions answered 1-10. Minimum final score value is 7 with maximum being 70. A higher score means a worse outcome.

  POSAS scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively

• Patient Satisfaction Likert Scale

  Overall patient satisfaction with post-operative scar appearance will be evaluated with 5 separate Likert Scale questions ranked 1-10 with higher scores demonstrating a worse outcome.

  Patient Satisfaction Likert scale will be administered at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively

• Vancouver Scar Scale

  Appearance of Forehead Donor Site will be assessed at determined post-operative intervals by a blinded attending surgeon using the Vancouver Scar Scale (VSS). This scale includes four categories that assess scar characteristics. Final scores have a minimum value of 0 and a maximum value of 13 with a higher score demonstrating a worse outcome.

  Assessed at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively

• Physician Graded Scar Metrics

  Appearance of Forehead Donor Site will be assessed at determined post-operative intervals by a blinded attending surgeon. Scar width (mm) as well as abnormal scar healing will be assessed and documented. Abnormal scar healing categories include none, hypertrophic scar, and keloid scar. No numeric values will be assigned to this scale.

  Assessed at 1 week, 1 month, 3 months, 6 months, and 1 year post-operatively

Secondary Outcomes (2)

• Side Effects

  1 week, 1 month, 3 months, 6 months, 1 year

• Wound Healing Complications

  1 week, 1 month, 3 months, 6 months, 1 year

Study Arms (2)

Dysport Arm

EXPERIMENTAL

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.

Drug: Abobotulinumtoxin-A

Placebo Arm

PLACEBO COMPARATOR

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.

Other: Control- Saline injection

Interventions

Abobotulinumtoxin-A DRUG

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

Dysport Arm

Control- Saline injection OTHER

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Galderma R&D: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Melanoma

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Shiayin F Yang, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole G DeSisto, MD

CONTACT

615-322-6180; nicole.g.desisto.1@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor- Department of Otolaryngology Head and Neck Surgery

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)