MedDataX Logo

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

NCT ID: NCT02623829

Last Updated: 2020-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2019-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-operative Excessive Scarring

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

scar prophylaxis Botulinum Toxin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Botulinum Toxin

Intervention Type DRUG

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

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.

Group Type SHAM_COMPARATOR

Saline

Intervention Type DRUG

1ml of normal saline will be administered

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Botulinum Toxin

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

Intervention Type DRUG

Saline

1ml of normal saline will be administered

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Botox, OnabotulinumtoxinA placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Michael Bernstein

Daniel Bernstein, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Michael Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Icahn School of Medicine at Mount Sinia

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23027220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16901024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10839391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11823931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19289689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15507786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12752512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15062252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9810991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16980850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19303834 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GCO 15-1093

Identifier Type: -

Identifier Source: org_study_id