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Post-operative Excessive Scarring clinical trials

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NCT ID: NCT02623829 Enrolling by invitation - Clinical trials for Post-operative Excessive Scarring

Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring (Allergan Botox Scar Study)

Start date: December 2015
Phase: Phase 2
Study type: Interventional

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. However, for optimal cosmetic and functional outcome, specific suture techniques are often necessary to ensure close wound approximation while simultaneously minimizing static tension along the wound edge. In addition, there are post-operative techniques for wound care that range from special dressings during the various stages of healing to cosmetic procedures for scar modification. Unfortunately, once the operation is complete, there is little the surgeon can do to minimize adverse scar formation without impairing the healing process. 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.