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Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

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ClinicalTrials.gov Identifier: NCT01459666
Recruitment Status : Recruiting
First Posted : October 26, 2011
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Margaret Mann, University Hospitals Cleveland Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Scar Drug: Dysport (abobotulinumtoxinA) Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle) Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Other Names:
  • AbobotulinumtoxinA
  • Clostridium botulinum type toxin A toxin-haemagglutinin complex
Placebo Comparator: Placebo Drug: Bacteriostatic 0.9% Sodium Chloride (vehicle)
Intramuscular injection



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrollment:

  • Ability to understand the risks, benefits, and alternative to participation and give informed consent
  • Have biopsy proven skin cancer on the medial forehead that is amenable to Mohs surgery. Medial forehead is defined as the area superiorly from the hairline, inferiorly at the eyebrow, and laterally to the tip of the lateral brow (see diagram).
  • Undergoing elective reconstruction of biopsy proven skin cancer that is amenable to Mohs surgery with defect size measuring 1.0 cm or greater
  • If female, not currently pregnant, no potential for pregnancy, or if of child-bearing age, must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for 30 days after the last dose of study drug. A negative urine pregnancy test is required at study entry for female subjects of childbearing potential: a woman is considered to be of child bearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oopherectomy, or is postmenopausal (without a menstrual period for at least one year)
  • Agrees to not use disallowed concomitant medications (retinoids)

Exclusion Criteria:

The presence of any of the following will exclude a patient from study enrollment.

  • Pregnant women, women who are breastfeeding, or women of child bearing age who are unwilling to use adequate contraception (described above) during the study period
  • Current or past history of a neuromuscular disease (such as myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
  • Currently taking aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents)
  • History of radiation therapy or chemotherapy
  • History of keloid or other hypertrophic scar formation
  • Current or past history of scleroderma
  • Has used botulinum toxin in the forehead area within one year.
  • Has significant resting eyebrow ptosis
  • Has used any topical retinoids to the forehead area within the past 4 weeks
  • Undergo any scar revision procedure for the duration of the study including intralesional kenalog, laser treatment, and/or scar revision surgeries
  • Any hypersensitivity to any component of abobotulinumtoxinA (i.e. cow milk protein) or any previous hypersensitivity to any botulinum toxin A or related product.
  • Non-English speaking: These patients are excluded since translation of the informed consent into other languages is time-consuming and expensive as it requires a bona fide translator for the particular language of interest and this type of person may be difficult to locate.
  • House staff and students, medical students on a clerkship, and employees related to study personnel or who work for any study personnel, and members of the study team are not eligible to participate in this study as a subject.
  • The investigator feels that for any reason the subject is not eligible to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459666


Contacts
Contact: Margaret Mann, MD 1-440-250-2452 margaret.mann@uhhospitals.org
Contact: Erich Zirzow, BS 216-844-7164 erich.zirzow@uhhospitals.org

Locations
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    margaret.mann@uhhospitals.org   
Principal Investigator: Margaret Mann, MD         
UH Cleveland Medical Center-Westlake Recruiting
Westlake, Ohio, United States, 44145
Contact: Francis Michaud, MA    440-250-2452    francis.michaud@uhhospitals.org   
Principal Investigator: Margaret Mann, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Margaret Mann, MD University Hospitals Cleveland Medical Center

Responsible Party: Dr. Margaret Mann, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01459666     History of Changes
Other Study ID Numbers: CASE1Z12
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: October 2017

Keywords provided by Dr. Margaret Mann, University Hospitals Cleveland Medical Center:
Scar
Forehead
Skin Cancer
MOHS Surgery
Dermatology

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Hemagglutinins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Agglutinins
Immunologic Factors