NCT04710719 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Al-Attar A, Mess S, Thomassen JM, Kauffman CL, Davison SP
Keloid pathogenesis and treatment. Plast Reconstr Surg. 2006 Jan;117(1):286-300. Review.
Davison SP, Dayan JH, Clemens MW, Sonni S, Wang A, Crane A
Efficacy of intralesional 5-fluorouracil and triamcinolone in the treatment of keloids. Aesthet Surg J. 2009 Jan-Feb;29(1):40-6. doi: 10.1016/j.asj.2008.11.006.
Khalid FA, Mehrose MY, Saleem M, Yousaf MA, Mujahid AM, Rehman SU, Ahmad S, Tarar MN
Comparison of efficacy and safety of intralesional triamcinolone and combination of triamcinolone with 5-fluorouracil in the treatment of keloids and hypertrophic scars: Randomised control trial. Burns. 2019 Feb;45(1):69-75. doi: 10.1016/j.burns.2018.08.011. Epub 2018 Oct 16.
Nicholas RS, Falvey H, Lemonas P, Damodaran G, Ghannem A, Selim F, Navsaria H, Myers S
Patient-related keloid scar assessment and outcome measures. Plast Reconstr Surg. 2012 Mar;129(3):648-656. doi: 10.1097/PRS.0b013e3182402c51. Erratum in: Plast Reconstr Surg. 2012 May;129(5):1213. Ghannem, Ali [corrected to Ghanem, Ali M].
Ren Y, Zhou X, Wei Z, Lin W, Fan B, Feng S
Efficacy and safety of triamcinolone acetonide alone and in combination with 5-fluorouracil for treating hypertrophic scars and keloids: a systematic review and meta-analysis. Int Wound J. 2017 Jun;14(3):480-487. doi: 10.1111/iwj.12629. Epub 2016 Jul 18. Review.
Wu XL, Gao Z, Song N, Liu W
[Clinical study of auricular keloid treatment with both surgical excision and intralesional injection of low-dose 5-fluorouracil and corticosteroids]. Zhonghua Yi Xue Za Zhi. 2009 Apr 28;89(16):1102-5. Chinese.

Efficacy of Post-Surgical Intralesional Injection With Triamcinolone Versus Triamcinolone Plus Fluorouracil in the Treatment of Keloids

Details for clinical trial NCT04710719

Clinical trial NCT04710719 - References