Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring (Allergan Botox Scar Study)
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborator:
Allergan
Treatments:
Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA