NCT01459666

Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of AbobotulinumtoxinA (BTX-A) in Improving Forehead Wounds After Mohs Micrographic Surgery and Reconstruction for Skin Cancer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test if the use of DysportTM (abobotulinumtoxinA) improves wound healing and scarring after Mohs surgery. Research in the laboratory as well as previous studies in humans have shown improved wound healing and scarring with the use of a similar medication called Botox. Dysport may improve wound healing and scarring by relaxing facial muscles and therefore minimizes the muscle tension and possibly the inflammation around the wound.

Detailed description

Primary Objective: -To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at 6 weeks post surgery. Secondary Objectives: * To evaluate efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Patient and Observer Assessment Scale (POSAS) at week 1, 6, and 24. * To evaluate the efficacy of using aboBTX-A to improve wound healing prior to Mohs micrographic surgery and reconstruction for skin cancer as measured by the Visual Analogue Scale (VAS) at week 1 and 24 post surgery. * To evaluate patient satisfaction * To evaluate safety (adverse events) This is a 6 month, prospective, multicenter, double-blinded, randomized, placebo-controlled study. A total of 40 male or female healthy volunteers, 20 in each arm, will be enrolled. Up to 10 more patients can be enrolled to account for patient drop-out. Subjects will all undergo Mohs micrographic surgical removal of a skin cancer lesion on the forehead followed by reconstruction. Subjects will be randomized to receive either aboBTX-A injection or placebo injection in the frontalis, procerus, and corrugator muscles prior to reconstruction. Photographs, POSAS, and clinical assessments will be taken immediately after initial wound closure, at 1 week follow-up, at 6 weeks follow-up, and at 6 months follow-up. Adverse events will also be reviewed at each study visit. After the completion of the study, the photographs will be assessed (blinded as to the patient identifiers) using a 10 cm visual analog scale (VAS). The first few photographs will be evaluated by the surgeons together to calibrate the VAS and ensure inter-reliability.

Conditions

• Scar

Interventions

Type	Name	Description
DRUG	Dysport (abobotulinumtoxinA)	Intramuscular injection effects lasting up to 3 months
DRUG	Bacteriostatic 0.9% Sodium Chloride (vehicle)	Intramuscular injection

Timeline

• Start date: 2011-09-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2011-10-26
• Last updated: 2022-05-26
• Results posted: 2022-05-26

Locations

2 sites across 1 country: United States