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

Sponsor

Henry Ford Health System (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05478551

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scar Hypertrophic Scar	Drug: Botulinum Toxin Drug: Normal saline	Phase 2/Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The injector, assessor, patient, and outcome assessor will be blinded to the treatment side and placebo side of injection.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 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
Placebo Comparator: Placebo 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 Normal saline will serve as the placebo control on the contralateral side of the back. Other Names: Placebo

Arm

Intervention/Treatment

Experimental: 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

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

Placebo Comparator: Placebo

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

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Primary Outcome Measure [3 months]
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Primary Outcome Measure [6 months]
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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