Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring (Allergan Botox Scar Study)
Condition: Post-operative Excessive Scarring
MeSH terms: Cicatrix
Intervention: Botulinum Toxin; Saline
Intervention description: 50 units of botulinum toxin diluted in 1ml of normal saline will be administered.; 1ml of normal saline will be administered
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: scar prophylaxis; Botulinum Toxin

Summary:

      Dermatological surgeons wear many hats to care for subjects with skin cancer. While their
      role in cancerous tissue removal results in superior cure rates, there is also a need for
      skilled excisional repair and effective wound healing regimens so the subject can heal with
      the least amount of scarring necessary. As such, numerous techniques have been developed for
      reducing the morbidity associated with excessive scarring. Various flaps and grafts allow the
      surgeon to approximate skin texture, thickness and adnexa with respect to the residual
      surrounding tissue. Optimal cosmetic and functional outcomes require close wound
      approximation with minimal static tension along the wound edge. In addition, there are
      post-operative wound care techniques that range from special dressings to cosmetic scar
      modification. To date, most surgical wounds are allowed to heal at least partially before
      scar revision or modulation is attempted.

      Botulinum toxin presents a unique opportunity for surgeons to affect scar formation
      throughout the duration of the healing process. These effects are likely independent and
      adjunctive to any and all wound care techniques, and are primarily attributed to a reduction
      in dynamic tension on the wound edges. Most importantly, botulinum toxin's one time dosing
      requirements with respect to reduced scar formation precludes the variance inherent to
      standard wound care practices.

      Therefore, it has been proposed that for selected subjects, botulinum toxin may be a safe,
      effective and reliable means for improved post-excisional repair outcomes. Botulinum toxin
      has been investigated as an inhibitor of excessive, post-excisional scar formation in plastic
      surgery and Otorhinolaryngology literature. However, these promising studies have yet to
      combine objective assessment measures of human scar formation in a randomized controlled
      trial. In addition, there are currently no formal studies of botulinum toxin as a
      prophylactic against excess scarring in the dermatological literature. Fortunately, Botulinum
      toxin dosing in the forehead for the purposes of inhibiting excessive scar formation is
      comparable to the amount given for cosmetic purposes, which is commonplace in dermatology and
      well-studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English-speaking adults at least 18 years old.

          -  Subjects must be scheduled for an excision of forehead skin due to any etiology, with
             a same day, single stage closure planned as the most likely surgical repair.

          -  Subjects must be able to read, sign, and understand the informed consent.

          -  Subject is willing and able to participate in the study as an outpatient, making
             several visits to the study center during the treatment and follow-up periods and to
             comply with all study requirements including concomitant medication and other
             treatment restrictions.

          -  If subject is a female of childbearing potential she must have a negative urine
             pregnancy test result prior to study treatment initiation and must agree to use an
             approved method of birth control while enrolled in the study.

        Exclusion Criteria:

          -  Subjects with an unstable medical condition as deemed by the clinical investigator,
             including review of the subject's prior and current medications.

          -  Subjects with Myasthenia gravis, Lambert-Eaton Syndrome or other neuromuscular
             disorder.

          -  Subjects taking medications that may alter the function of neuromuscular junctions
             (i.e. aminoglycoside antibiotics)

          -  Women who are pregnant, lactating, or planning to become pregnant during the study
             period.

          -  Subjects who have a history of keloids.

          -  Known allergy to botulinum toxin.

          -  Subjects who are not able to be closed with a same day, single stage technique.