Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
Condition: Scar
MeSH terms: Skin Neoplasms
Intervention: Dysport (abobotulinumtoxinA); Bacteriostatic 0.9% Sodium Chloride (vehicle)
Intervention description: Intramuscular injection effects lasting up to 3 months; Intramuscular injection
Intervention MeSH terms: Hemagglutinins; abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Scar; Forehead; Skin Cancer; MOHS Surgery; Dermatology

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.
    

Eligibility 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