Treatment of keloids using 5-fluorouracil in combination with crystalline triamcinolone acetonide suspension: evaluating therapeutic effects by using non-invasive objective measures

Abstract

Background: Intralesional 5-fluorouracil (5-FU) in combination with triamcinolone acetonide (TAC) has been recommended as a promising alternative for keloids not responding to silicone-based products, cryotherapy or intralesional corticosteroids alone. Although numerous studies support the efficacy of this regime, there is a lack of objective data. Objectives: In this study, we evaluate the therapeutic effect of four courses of intralesional 5-FU in combination with TAC (3 : 1) utilizing 3D analysis (PRIMOS®pico), ultrasound and scar scales such as the Patient and Observer Scar Assessment Scales (POSAS) and the Dermatology Life Quality Index (DLQI). Methods: Twenty-five patients with keloids were treated using 5-FU and TAC every 4 weeks. Objective assessments were performed and the scar scales administered at baseline, as well as during consecutive visits at 1- and 12-month follow-up (FU). Routine laboratory tests were performed at baseline and at 1-month FU. Results: 3D PRIMOS and ultrasound measurements revealed highly significant and stable reductions in height (baseline mean score: 4.0 ± 1.7 mm, 1-month FU mean score: 1.5 ± 0.8 mm, 12-month FU mean score: 1.8 ± 0.9 mm, P = <0.0001), volume (baseline mean score: 1,105 ± 911.5 mm3, 1-month FU mean score: 416.1 ± 218.1 mm3, 12-month FU mean sore: 431.2 ± 253.6 mm3, P = <0.0001, respectively) and penetration depth of keloids (relative reduction between baseline and 12-month FU of 74.4%, P = <0.0001). The POSAS and DLQI scales confirmed significant objective and subjective improvements in scar appearance in all categories. The life quality associated with keloid appearance improved from a ‘moderate effect’ to a ‘small effect’ throughout the course of the study. Conclusions: Results of this study confirm the efficacy and safety of the combination of 5-FU and TAC in keloids. Treatments were well tolerated and demonstrated stable results at 12-month FU.