drugset / Trial / NCT06230146
Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin, Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid: A Clinical, Dermoscopic and Immunohistochemical Study.
RandomizedParallel-groupDouble-blindTreatment
Summary
Keloids are macroscopic cutaneous scarring that result from disturbance of wound healing, that occurs on predisposed individuals . Keloid shows a kind of over-healing, producing over abundant wound matrix responsible for raised, inflexible red scar tissue, that causes pain and itching .
Timeline
- Start
- 2024-05-01
- Primary completion
- 2026-01-01
- Completion
- 2026-05-01
Publications
- Background Ogawa R. Keloid and Hypertrophic Scars Are the Result of Chronic Inflammation in the Reticular Dermis. Int J Mol Sci. 2017 Mar 10;18(3):606. doi: 10.3390/ijms18030606.
- Background Ohtsuru A, Yoshimoto H, Ishihara H, Namba H, Yamashita S. Insulin-like growth factor-I (IGF-I)/IGF-I receptor axis and increased invasion activity of fibroblasts in keloid. Endocr J. 2000 Mar;47 Suppl:S41-4. doi: 10.1507/endocrj.47.supplmarch_s41.
- Background Betarbet U, Blalock TW. Keloids: A Review of Etiology, Prevention, and Treatment. J Clin Aesthet Dermatol. 2020 Feb;13(2):33-43. Epub 2020 Feb 1.
- Background Walsh LA, Wu E, Pontes D, Kwan KR, Poondru S, Miller CH, Kundu RV. Keloid treatments: an evidence-based systematic review of recent advances. Syst Rev. 2023 Mar 14;12(1):42. doi: 10.1186/s13643-023-02192-7.
- Background Thornton NJ, Garcia BA, Hoyer P, Wilkerson MG. Keloid Scars: An Updated Review of Combination Therapies. Cureus. 2021 Jan 30;13(1):e12999. doi: 10.7759/cureus.12999.
- Background 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.
- Background Wang J, Xu J. Effects of Topical Insulin on Wound Healing: A Review of Animal and Human Evidences. Diabetes Metab Syndr Obes. 2020 Mar 13;13:719-727. doi: 10.2147/DMSO.S237294. eCollection 2020.
- Background Zhang Z, Lv L. Effect of local insulin injection on wound vascularization in patients with diabetic foot ulcer. Exp Ther Med. 2016 Feb;11(2):397-402. doi: 10.3892/etm.2015.2917. Epub 2015 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 2.5 iu | Other |
| Subject | Insulin | Protein / enzyme biologic | 0.1 ml | Other |
| Subject | Triamcinolone Acetonide | Other / unclassified | 40 mg | Other |