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Active, Not Recruiting

NCT Number: NCT05478551

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

The process of scar formation is denoted by three stages: inflammatory, proliferative, and remodeling. The former phase is characterized by the activation of the extrinsic clotting pathway and subsequent materialization of a fibrin plug, after which neutrophils facilitate the degradation of pathogens and secretion of signaling molecules that commence the proliferative phase. The fibrin plug is then replaced by granulation tissue comprised of macrophages, fibroblast, and endothelial cells in the proliferative phase. Through the release several growth factors, existing macrophages induce laying down of type III collagen by fibroblasts, and keratinocytes work in tandem to approximate wound edges. Lastly, during the remodeling phase, cellular apoptosis causes granulation tissue formation to subside, type III collagen is replaced by a more durable collagen type I, and myofibroblasts help to condense the scar size.1,2

While scarring in its non-pathological forms is an innate and appropriate bodily response to cutaneous injury, scar development and persistence can have negative physical and psychological implications, including decreased range of motion secondary to contracture, disfigurement, and impaired quality of life.1,3-5 Thus, for medical and cosmetic purposes alike, curtailing scar formation is important aspect of patient management, and treatment aimed at both prevention and resolution is an evolving subject in the medical discourse. Credence has been given to the use of botulinum toxin A (BTA) in scar minimization, a more novel therapy, and has proved efficacious in several studies including those examining BTA in the treatment of keloids and hypertrophic scars, mammoplasty and abdominoplasty surgery scars, and post-operative scars generally.6-9 The suggested mechanisms for this phenomenon involve inhibition of pre-synaptic acetylcholine channels that lead to muscle paralysis and relaxation of perpendicular wound tension; this particular mechanism is likewise theorized to mitigate collagen overproduction. Another hypothesis for explaining the ability of BTA to reduce scar appearance is the direct modulation of fibroblast activity.6

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Dysport, BTXa, abobotulinumtoxinA

normal saline

Drug

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

Other names: Placebo

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 3 months

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

  2. Primary Outcome Measure

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2022
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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