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

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT02623829
Collaborator
Allergan (Industry)
42
Enrollment
1
Location
2
Arms
39
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Botulinum Toxin is a Potential Prophylactic Therapy for Minimizing Post-excisional Scarring: A Double Blinded, Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Botulinum Toxin

50 units of botulinum toxin diluted in 1ml of normal saline will be administered. The forehead will be injected with 12, evenly spaced and symmetrical aliquots of 0.05ml(2.5 units) and the glabella will be injected at the nasal root and the medial aspect of the corrugators with 0.1ml(5 units) each in addition to the lateral aspect of each corrugator with 0.05ml(2.5 units). The injections will be administered with a 30G needle perpendicular to the skin.

Drug: Botulinum Toxin
50 units of botulinum toxin diluted in 1ml of normal saline will be administered.
Other Names:
  • Botox,
  • OnabotulinumtoxinA

    		•
    Sham Comparator: Saline

    1ml of normal saline will be injected with 12, evenly spaced and symmetrical aliquots of 0.05ml and the glabella will be injected at the nasal root and the medial aspect of the corrugators with 0.1ml each in addition to the lateral aspect of each corrugator with 0.05ml. The injections will be administered with a 30G needle perpendicular to the skin.

    Drug: Saline
    1ml of normal saline will be administered
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Manchester Scar Scale (MMSS) Score [6 months]

      MMSS scores range 5-18, higher score indicates poorer health outcomes. The MMSS assesses color, texture, distortion and contour of the scar.

    Secondary Outcome Measures

    1. Visual Analog Scar Scale [6 months]

      Visual Analog Scar Scale (VASS), full score range 0-10 higher score indicates poorer health outcomes

    2. Scar Width [6 months]

      Scar width at 6 months after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Icahn School of Medicine at Mount Sinia New York New York United States 10029

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai
    • Allergan

    Investigators

    • Principal Investigator: Daniel Michael Bernstein, MD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Daniel Michael Bernstein, Daniel Bernstein, MD, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT02623829
    Other Study ID Numbers:
    • GCO 15-1093
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Daniel Michael Bernstein, Daniel Bernstein, MD, Icahn School of Medicine at Mount Sinai
    scar prophylaxis
    Botulinum Toxin
    Additional relevant MeSH terms:
    Cicatrix
    Botulinum Toxins
    Botulinum Toxins, Type A

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Botulinum Toxin Saline
    Arm/Group Description subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
    Period Title: Overall Study
    STARTED 21 21
    COMPLETED 20 20
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Botulinum Toxin Saline Total
    Arm/Group Description subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds Total of all reporting groups
    Overall Participants 20 20 40
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    57
    59
    58
    Sex: Female, Male (Count of Participants)
    Female
    8
    40%
    9
    45%
    17
    42.5%
    Male
    12
    60%
    11
    55%
    23
    57.5%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    20
    100%
    20
    100%
    40
    100%
    Smoking history (Count of Participants)
    Count of Participants [Participants]
    2
    10%
    2
    10%
    4
    10%
    Autoimmune conditions (Count of Participants)
    Count of Participants [Participants]
    1
    5%
    1
    5%
    2
    5%
    Scar location (Count of Participants)
    Median forehead
    2
    10%
    2
    10%
    4
    10%
    Paramedian forehead
    10
    50%
    10
    50%
    20
    50%
    Lateral forehead
    8
    40%
    8
    40%
    16
    40%
    Scar length (mm) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [mm]
    58
    54
    55

    Outcome Measures

    1. Primary Outcome
    Title Modified Manchester Scar Scale (MMSS) Score
    Description MMSS scores range 5-18, higher score indicates poorer health outcomes. The MMSS assesses color, texture, distortion and contour of the scar.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Botulinum Toxin Saline
    Arm/Group Description subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
    Measure Participants 20 20
    Median (Inter-Quartile Range) [score on a scale]
    8
    11.5
    2. Secondary Outcome
    Title Visual Analog Scar Scale
    Description Visual Analog Scar Scale (VASS), full score range 0-10 higher score indicates poorer health outcomes
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Botulinum Toxin Saline
    Arm/Group Description subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
    Measure Participants 20 20
    Median (Inter-Quartile Range) [score on a scale]
    2
    3.5
    3. Secondary Outcome
    Title Scar Width
    Description Scar width at 6 months after treatment
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Botulinum Toxin Saline
    Arm/Group Description subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
    Measure Participants 20 20
    Median (Inter-Quartile Range) [mm]
    2.2
    3.2

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description
    Arm/Group Title Botulinum Toxin Saline
    Arm/Group Description subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds
    All Cause Mortality
    Botulinum Toxin Saline
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)
    Serious Adverse Events
    Botulinum Toxin Saline
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    Botulinum Toxin Saline
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/20 (5%) 0/20 (0%)
    Eye disorders
    mild unilateral eyelid ptosis 1/20 (5%) 0/20 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Daniel Bernstein
    Organization Icahn School of Medicine at Mount Sinai
    Phone 212-731-3311
    Email daniel.bernstein@mountsinai.org
    Responsible Party:
    Daniel Michael Bernstein, Daniel Bernstein, MD, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT02623829
    Other Study ID Numbers:
    • GCO 15-1093
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Nov 1, 2020