Introduction: Keloids scars can be uncomfortable, disfiguring and aesthetically undesirable. Our initial work with low dose intralesional fluorouracil (5-FU) showed it to be useful for controlling the growth of keloids and hypertrophic scars.  Our hypothesis for this project was that intralesional 5-FU is more effective at controlling keloid scar growth and symptoms related to recurrant keloid scars than corticosteroids. Our outcome measures were scar volume and symptoms inventory. 

 Method: An institutionally approved prospective randomized study was designed. All patients had failed previous steroid therapy and/or excision. All patient agreed to possible off-label use of 5-FU. All patients underwent excision of the scar followed by regular injections of either 60 mg of Kenalog 40 (Triamcinolone) or 50 mg fluorouracil. No patient received more than 10 injections within the 12 months treatment window. Patients were then followed for an additional one year off therapy. Patient questionnaires were completed at specific intervals. Molds were made of the scars at four timepoints; pre-excision, post-excision, after completion of the 12 month treatment protocol and one year post-treatment (off therapy). Molds were made using Thixotrophic Vinyl Polysiloxane an isothermic dental mold material. Volume displacement was employed to determine volume of each scar.

Results: 38 patients completed the treatment protocol as well as the one year monitoring off treatment. Scar volumes this timepoint (post treatment) were 0.60 ± 0.40 cm³ for the steroid group and 0.44 ± 0.01 cm³ for the 5-FU group. There was no statistically significant difference between the groups at this timepoint. Reported symptom improvement was 72% for the steroid group and 75% for the fluorouracil group. . Recurrence was defined as ≥ 50% increase in measured scar volume relative to the original scar volume. Post treatment only the steroid-treatment group had a single recurrence. There were no recurrences in the fluorouracil group at that timepoint. At the one year follow-up (off treatment) mean scar volume was 0.97 ± 0.57 cm³ for the steroid group and 0.47 ± 0.39 cm³ for the fluorouracil group. The steroid-treated scars were statistically significantly larger than the fluorouracil-treated scars at one year follow up (p < 0.01). Additionally, the steroid group had three recurrences and the fluorouracil group had one at one-year follow-up. With regards to subjective symptom relief at one year, it decreased by two patients in the steroid group (61% of patients stated improvement) and one patient in the fluorouracil group (70%). The steroid group had no complications. The fluorouracil group had two patients with skin breakdown at the injection site during a single treatment. Both of these patients healed and went on to complete the treatment protocol without further difficulty. Conclusion: We used a prospective randomized study model to evaluate the role of two different medications in the management of recalcitrant keloids. No statistical difference was noted at the completion of the 12 months of treatment between the medications. At one year post treatment, the steroid treatment group not only had more cases of recurrence but also a statistically significant overall volume growth of the scars compared to the fluorouracil treatment group. Fluorouracil maintained the scar volume one year post-treatment. Our method of tracking the scars included both subjective symptoms and volume analysis. Symptom improvement was similar between the two groups and did not change much after a year off therapy. Our results show that post excision scar volume is better maintained long-term with fluorouracil compared to triamcinolone. Minimal morbidity was noted in the fluorouracil group. In our hands, volumetric analysis in conjunction with patient symptoms rating is a straightforward method for evaluating scar treatment protocols. Volumetric tracking of scars is a safe, reliable and reproducible technique for evaluating and comparing scar therapies. It allows for objective comparison of lesions regardless of location, orientation or shape. Intralesional fluorouracil is a safe and effective means of controlling problem scars both is terms of scar size and symptom control. It should be considered as another option for patients suffering from problematic scars.