Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization

NCT05478551 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 15432
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study seeks to evaluate the scar reduction capacity of BTA on excision/biopsy wounds compared to the control (normal saline) in a double-blinded randomized control trial. It will expand upon previous studies that have already demonstrated the safety and good tolerance profile of BTA. We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control. In keeping with the results from previously conducted studies, we hypothesize that the wounds treated with BTA will have significantly less evidence of scar formation than those sites treated with normal saline.

Conditions

Scar; Hypertrophic Scar

Keywords

botulinum toxin; scar prevention; scar formation

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Measure

  Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)

  3 months

• Primary Outcome Measure

  Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)

  6 months

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

Biopsy site receiving botulinum toxin Following the biopsy closures, one of two biopsy sites (left or right) will be selected to receive 30u (0.3cc) of botulinum toxin injected into the suture line at a depth of PPD bleb. The treatment for each wound site will be randomized (left versus right) and blinded but consistent throughout dosing.

Drug: Botulinum Toxin

Placebo

PLACEBO COMPARATOR

Placebo Comparator: Biopsy site receiving placebo Following the biopsy closures, the other biopsy site will receive 30u (0.3cc) of bacteriostatic normal saline injected into the suture line at a depth of PPD bleb.

Drug: Normal saline

Interventions

Botulinum Toxin DRUG

We will be comparing botulinum toxin following the biopsies to placebo injection. We will then compare photos of each biopsy site at set intervals following the procedure.

Also known as: Dysport, BTXa, abobotulinumtoxinA

Botulinum toxin

Normal saline DRUG

Normal saline will serve as the placebo control on the contralateral side of the back.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Individuals age 18 and older
• Able to understand the requirements of the study and its associated risks
• Able to complete and sign a consent form

You may not qualify if:

• Allergy to botulinum toxin
• Currently pregnant or breastfeeding
• Myasthenia gravis
• Previous injection of botulinum toxin in the specified treatment areas within 6 months prior to enrollment
• Unable to follow up 6 months after biopsy procedure
• Refusal to participate in the trial
• History of keloid or hypertrophic scars
• Eaton-Lambert Syndrome
• Amyopathic Lateral Sclerosis

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (8)

• Tziotzios C, Profyris C, Sterling J. Cutaneous scarring: Pathophysiology, molecular mechanisms, and scar reduction therapeutics Part II. Strategies to reduce scar formation after dermatologic procedures. J Am Acad Dermatol. 2012 Jan;66(1):13-24; quiz 25-6. doi: 10.1016/j.jaad.2011.08.035.

  PMID: 22177632 RESULT

• Kasyanju Carrero LM, Ma WW, Liu HF, Yin XF, Zhou BR. Botulinum toxin type A for the treatment and prevention of hypertrophic scars and keloids: Updated review. J Cosmet Dermatol. 2019 Feb;18(1):10-15. doi: 10.1111/jocd.12828. Epub 2018 Dec 12.

  PMID: 30548742 RESULT

• Oosterwijk AM, Mouton LJ, Schouten H, Disseldorp LM, van der Schans CP, Nieuwenhuis MK. Prevalence of scar contractures after burn: A systematic review. Burns. 2017 Feb;43(1):41-49. doi: 10.1016/j.burns.2016.08.002. Epub 2016 Sep 14.

  PMID: 27639820 RESULT

• Oh H, Boo S. Assessment of burn-specific health-related quality of life and patient scar status following burn. Burns. 2017 Nov;43(7):1479-1485. doi: 10.1016/j.burns.2017.03.023. Epub 2017 May 21.

  PMID: 28539239 RESULT

• Ziolkowski N, Kitto SC, Jeong D, Zuccaro J, Adams-Webber T, Miroshnychenko A, Fish JS. Psychosocial and quality of life impact of scars in the surgical, traumatic and burn populations: a scoping review protocol. BMJ Open. 2019 Jun 3;9(6):e021289. doi: 10.1136/bmjopen-2017-021289.

  PMID: 31164358 RESULT

• Abedini R, Mehdizade Rayeni N, Haddady Abianeh S, Rahmati J, Teymourpour A, Nasimi M. Botulinum Toxin Type A Injection for Mammoplasty and Abdominoplasty Scar Management: A Split-Scar Double-Blinded Randomized Controlled Study. Aesthetic Plast Surg. 2020 Dec;44(6):2270-2276. doi: 10.1007/s00266-020-01916-7. Epub 2020 Aug 19.

  PMID: 32813130 RESULT

• Yang W, Li G. The Safety and efficacy of botulinum toxin type A injection for postoperative scar prevention: A systematic review and meta-analysis. J Cosmet Dermatol. 2020 Apr;19(4):799-808. doi: 10.1111/jocd.13139. Epub 2019 Sep 12.

  PMID: 31513335 RESULT

• Guo X, Song G, Zhang D, Jin X. Efficacy of Botulinum Toxin Type A in Improving Scar Quality and Wound Healing: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthet Surg J. 2020 Apr 14;40(5):NP273-NP285. doi: 10.1093/asj/sjz165.

  PMID: 31155638 RESULT

MeSH Terms

Conditions

Cicatrix; Cicatrix, Hypertrophic

Interventions

Botulinum Toxins; abobotulinumtoxinA; Saline Solution

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• David Ozog, MD

  Henry Ford Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The injector, assessor, patient, and outcome assessor will be blinded to the treatment side and placebo side of injection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Model Details: We will be conducting a split-scar study/study involving two biopsy sites in a singular patient, allowing them to serve as their own control.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)