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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin | Experimental | 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. |
|
| Saline | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin | Drug | 50 units of botulinum toxin diluted in 1ml of normal saline will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Manchester Scar Scale (MMSS) Score | MMSS scores range 5-18, higher score indicates poorer health outcomes. The MMSS assesses color, texture, distortion and contour of the scar. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scar Scale | Visual Analog Scar Scale (VASS), full score range 0-10 higher score indicates poorer health outcomes | 6 months |
| Scar Width | Scar width at 6 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Michael Bernstein, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinia | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23027220 | Background | Jablonka EM, Sherris DA, Gassner HG. Botulinum toxin to minimize facial scarring. Facial Plast Surg. 2012 Oct;28(5):525-35. doi: 10.1055/s-0032-1325641. Epub 2012 Oct 1. | |
| 16901024 | Background | Gassner HG, Brissett AE, Otley CC, Boahene DK, Boggust AJ, Weaver AL, Sherris DA. Botulinum toxin to improve facial wound healing: A prospective, blinded, placebo-controlled study. Mayo Clin Proc. 2006 Aug;81(8):1023-8. doi: 10.4065/81.8.1023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin | subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds |
| FG001 | Saline | subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin | subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds |
| BG001 | Saline | subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Manchester Scar Scale (MMSS) Score | MMSS scores range 5-18, higher score indicates poorer health outcomes. The MMSS assesses color, texture, distortion and contour of the scar. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin | subcutaneous injections of onabotulinumtoxinA (1 mL = 50 units) immediately following closure of forehead wounds |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild unilateral eyelid ptosis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Bernstein | Icahn School of Medicine at Mount Sinai | 212-731-3311 | daniel.bernstein@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2015 | Oct 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Saline | Drug | 1ml of normal saline will be administered |
|
|
| 6 months |
| 10839391 | Background | Gassner HG, Sherris DA, Otley CC. Treatment of facial wounds with botulinum toxin A improves cosmetic outcome in primates. Plast Reconstr Surg. 2000 May;105(6):1948-53; discussion 1954-5. doi: 10.1097/00006534-200005000-00005. |
| 11823931 | Background | Sherris DA, Gassner HG. Botulinum toxin to minimize facial scarring. Facial Plast Surg. 2002 Feb;18(1):35-9. doi: 10.1055/s-2002-19825. |
| 19289689 | Background | Gassner HG, Sherris DA, Friedman O. Botulinum toxin-induced immobilization of lower facial wounds. Arch Facial Plast Surg. 2009 Mar-Apr;11(2):140-2. doi: 10.1001/archfacial.2009.3. No abstract available. |
| 15507786 | Background | Carruthers J, Fagien S, Matarasso SL; Botox Consensus Group. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004 Nov;114(6 Suppl):1S-22S. doi: 10.1097/01.PRS.0000144795.76040.D3. |
| 12752512 | Background | Carruthers A, Carruthers J, Cohen J. A prospective, double-blind, randomized, parallel- group, dose-ranging study of botulinum toxin type a in female subjects with horizontal forehead rhytides. Dermatol Surg. 2003 May;29(5):461-7. doi: 10.1046/j.1524-4725.2003.29114.x. |
| 15062252 | Background | Zimbler MS, Nassif PS. Adjunctive applications for botulinum toxin in facial aesthetic surgery. Facial Plast Surg Clin North Am. 2003 Nov;11(4):477-82. doi: 10.1016/S1064-7406(03)00071-3. |
| 9810991 | Background | Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998 Nov;102(6):1954-61. doi: 10.1097/00006534-199811000-00022. |
| 16980850 | Background | Duncan JAL, Bond JS, Mason T, Ludlow A, Cridland P, O'Kane S, Ferguson MWJ. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality? Plast Reconstr Surg. 2006 Sep 15;118(4):909-918. doi: 10.1097/01.prs.0000232378.88776.b0. |
| 19303834 | Background | Durani P, McGrouther DA, Ferguson MW. Current scales for assessing human scarring: a review. J Plast Reconstr Aesthet Surg. 2009 Jun;62(6):713-20. doi: 10.1016/j.bjps.2009.01.080. Epub 2009 Mar 20. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Autoimmune conditions | Count of Participants | Participants |
|
| Scar location | Count of Participants | Participants |
|
| Scar length | Median | Inter-Quartile Range | mm |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Visual Analog Scar Scale | Visual Analog Scar Scale (VASS), full score range 0-10 higher score indicates poorer health outcomes | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Secondary | Scar Width | Scar width at 6 months after treatment | Posted | Median | Inter-Quartile Range | mm | 6 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Saline | subcutaneous injections of saline (1 mL) immediately following closure of forehead wounds | 0 | 20 | 0 | 20 | 0 | 20 |
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| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |