What is the efficacy of 5-fluorouracil (5-FU) for the treatment of keloids and hypertrophic scars?

Updated: May 29, 2020
  • Author: Brian Berman, MD, PhD; Chief Editor: Dirk M Elston, MD  more...
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In a retrospective study of 1000 patients with hypertrophic scars and keloids over a 9-year period, the most effective regimen was found to be 0.1 mL of TAC (10 mg/mL) and 0.9 mL of 5-FU (50 mg/mL) up to 3 times a week.

A total of 85% of keloids showed more than 50% improvement in an open study by Kontochristopoulos et al in which 20 keloids were treated once weekly with intralesional 5-FU (50 mg/mL) for an average of 7 treatments, with a recurrence rate of 47% within 1 year of the treatment. The Ki-67 proliferative index was significantly reduced (P = .0001) after treatment. [19]

Nanda and Reddy treated 28 patients with multiple keloids in a prospective, randomized, uncontrolled clinical trial with weekly intralesional injections of 5-FU at 50 mg/mL and reported almost 80% of the patients showing more than 50% improvement. Regression from the periphery and flattening occurred in all patients. In 22 of 28 patients, the symptoms completely disappeared, while the rest showed a good response. Decrease in size was reported in 70% of the patients. [20]

5-FU in combination with other therapies significantly increases the efficacy over single modalities.

In a double-blind randomized study, 40 patients with keloids or hypertrophic scars received 8 weekly intralesional injections of TAC 10 mg/mL or a combination of TAC 4 mg/mL plus 5-FU 45 mg/mL. At week 12, both groups showed improvement; however, the lesions in the TAC plus 5-FU group had significantly greater pliability and less erythema, height, length, and width (P< .05) than the TAC group compared with baseline (P<.05).<ref>21</ref>

In a randomized clinical trial by Asilian et al, 69 patients with keloids and hypertrophic scars were treated with a combination of 5-FU (50 mg/mL), TAC (40 mg/mL), and a 585-nm flashlamp-pumped pulsed-dye laser (PDL) at 5-7.5 J/cm2, showing that it was more effective than the TAC and TAC plus 5-FU. [22] At week 12, a statistically significant reduction in length, height, and width was observed in all groups compared with baseline (P< .05). In a randomized clinical trial, Manuskiatti and Fitzpatrick found a statistically significant clinical improvement in keloidal and hypertrophic sternotomy scars using these 3 modalities separately and a combination of TAC and 5-FU compared with baseline. No difference was found between the 4 treatment modalities. [23]

5-FU was used to treat a patient with keloids and hypertrophic scars post facial dermabrasion. The patient received 6 intralesional injections of 5-FU with silicone sheets applied afterwards over a 3-month span. During 7 months of follow up, a significant improvement in the size, color, and texture of the scars was noticed. In addition, the pain and itching had fully resolved. [24]

Sadeghinia et al compared the use of intralesional TAC 40 mg/mL at 20 mg/cm2 of lesion and 5-FU (50 mg/ml) tattooing in a double blind study. Forty patients were randomized into 2 groups, which received the treatment every 4 weeks for 12 weeks. At week 44, both groups showed improvement in all parameters (erythema, pruritus, height, surface, and induration), but improvement was more significant in the 5-FU group (P< .05). [25]

Although some studies have shown good results, it appears triamcinolone is a better-tolerated and less toxic alternative to 5-FU in the management of keloids. [26]

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