drugset / Trial / NCT05478551
Randomized Controlled Trial Examining the Efficacy of Botulinum Toxin in Biopsy Scar Minimization
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2022-06-01
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin | Protein / enzyme biologic | 30 iu | Other |