Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
|ClinicalTrials.gov Identifier: NCT01459666|
Recruitment Status : Recruiting
First Posted : October 26, 2011
Last Update Posted : September 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Scar||Drug: Dysport (abobotulinumtoxinA) Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)||Phase 4|
-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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Dysport (abobotulinumtoxinA)
Each patient will be able to receive up to 120 units of Dysport/placebo at the initial visit to treat the entire forehead area (the frontalis, procerus, and corrugator muscles) to insure cosmetic symmetry. Injections will be placed a minimum of 1.5cm above the orbital rim at the mid papillary line to minimize the risk of lid ptosis. The actual amount to be injected will be at the discretion of the Mohs surgeon based on his or her opinion of what amount is needed for sufficient wound paralysis and cosmetic symmetry.
Drug: Dysport (abobotulinumtoxinA)
Intramuscular injection effects lasting up to 3 months
|Placebo Comparator: Placebo||
Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)
- Visual Analogue Scale (VAS) [ Time Frame: 6 weeks post surgery ]It consists of a 10 point scale to assess global scar assessment. Scar photographic images are assessed by independent physicians, and previous studies have shown very high intrarater consistency.
- Patient and Observer Assessment Scale (POSAS) [ Time Frame: at week 1, 6, and 24 post surgery ]The Patient and Observer Scar Assessment Scale (POSAS) consists of two numeric scales. One scale is completed by the patients, the other by the clinician. This scale is different than previous scales because it takes the patient's input into consideration. It has good internal consistency and interobserver reliability. The assessment will take place at Day 0, Week 1, Week 6, and Month 6.
- Visual Analogue Scale (VAS) [ Time Frame: at week 1 and 24 post surgery ]Evaluate 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459666
|Contact: Margaret Mann, MDfirstname.lastname@example.org|
|Contact: Erich Zirzow, BSemail@example.com|
|United States, Ohio|
|University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Margaret Mann, MD 440-250-2452 firstname.lastname@example.org|
|Principal Investigator: Margaret Mann, MD|
|UH Cleveland Medical Center-Westlake||Recruiting|
|Westlake, Ohio, United States, 44145|
|Contact: Francis Michaud, MA 440-250-2452 email@example.com|
|Principal Investigator: Margaret Mann, MD|
|Principal Investigator:||Margaret Mann, MD||University Hospitals Cleveland Medical Center|