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

NCT02623829 | Completed Phase 2 Results

• 1 other identifier: GCO 15-1093
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Excessive Scarring

Keywords

scar prophylaxis; Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Visual Analog Scar Scale

  6 months

• Scar Width

  6 months

Study Arms (2)

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.

Drug: Botulinum Toxin

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.

Drug: Saline

Interventions

Botulinum Toxin DRUG

50 units of botulinum toxin diluted in 1ml of normal saline will be administered.

Also known as: Botox,, OnabotulinumtoxinA

Botulinum Toxin

Saline DRUG

1ml of normal saline will be administered

Also known as: placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Allergan: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinia

New York, New York, 10029, United States

Location

Related Publications (11)

• 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.

  PMID: 23027220 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.

  PMID: 16901024 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.

  PMID: 10839391 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.

  PMID: 11823931 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.

  PMID: 19289689 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.

  PMID: 15507786 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.

  PMID: 12752512 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.

  PMID: 15062252 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.

  PMID: 9810991 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.

  PMID: 16980850 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.

  PMID: 19303834 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins; Botulinum Toxins, Type A; Sodium Chloride

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Daniel Bernstein
• Organization: Icahn School of Medicine at Mount Sinai

daniel.bernstein@mountsinai.org

212-731-3311

Study Officials

• Daniel Michael Bernstein, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel Bernstein, MD

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 8, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 8, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-11

Locations

US (1)