Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring (Allergan Botox Scar Study)
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/10/2019 |
| Start Date: | December 2015 |
| End Date: | April 2019 |
Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring: A Double Blinded, Randomized Controlled Trial
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.
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.
This study will attempt to assess the efficacy of Botulinum toxin as a prophylactic treatment
in post-excisional repairs for the purpose of preventing excess scar formation. The end
points will be the evaluation of each scar using the Manchester Scar Scale.
All MSS and mMSS assessments will be performed in a standardized fashion. The mMSS
assessments will be blinded and performed by board-certified dermatologists in the Department
of Dermatology, Faculty Practice Associates, Icahn School of Medicine at Mount Sinai, New
York City.
in post-excisional repairs for the purpose of preventing excess scar formation. The end
points will be the evaluation of each scar using the Manchester Scar Scale.
All MSS and mMSS assessments will be performed in a standardized fashion. The mMSS
assessments will be blinded and performed by board-certified dermatologists in the Department
of Dermatology, Faculty Practice Associates, Icahn School of Medicine at Mount Sinai, New
York City.
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.
We found this trial at
1
site
New York, New York 10029
Principal Investigator: Daniel Michael Bernstein, MD
Phone: 212-241-3288
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