Background: Keloids and hypertrophic scars are benign growths of dermal collagen that usually cause major physical, psychological, and cosmetic problems.
Methods: In this 12-week single-blinded clinical trial, 69 patients were randomly assigned into three study groups. In Group 1, intralesional triamcinolone acetonide (TAC, 10 mg/mL) was injected at weekly intervals for a total of 8 weeks. In Group 2 [TAC+5-fluorouracil (5-FU)], 0.1 mL of 40 mg/mL TAC was added to 0.9 mL of 5-FU (50 mg/mL). This combination was injected weekly for 8 weeks. In Group 3, in addition to weekly TAC+5-FU injection for 8 weeks, lesions were irradiated by 585-nm flashlamp-pumped pulsed-dye laser (PDL, 5-7.5 J/cm2) at the 1st, 4th, and 8th weeks. Lesions were assessed for erythema, pruritus, pliability, height, length, and width.
Results: Sixty patients completed the study. At the 8- and 12-week follow-up visits, all groups showed an acceptable improvement in nearly all measures, but in comparison between groups, these were statistically more significant in the TAC+5-FU and TAC+5-FU+PDL groups (p<.05 for all). At the end of the study, the erythema score was significantly lower, and itch reduction was statistically higher in the TAC+5-FU+PDL group (p<.05 for both). Good to excellent improvements (>50% improvement) were reported by the patients as follows: 20% in Group 1, 55% in Group 2, and 75% in Group 3, all of which were significantly different (p<.05). Good to excellent responses were reported by the blinded observer as follows: 15% in Group 1, 40% in Group 2, and 70% in Group 3. Their differences were statistically significant (p<.05). Atrophy and telangiectasia were seen in 37% of patients in TAC group.
Conclusion: Overall efficacy of TAC+5-FU was comparable with TAC+5-FU+PDL, but the TAC+5-FU+PDL combination was more acceptable by the patients and produced better results. Its effect on lightening of the lesion was promising. The TAC+5-FU+PDL combination seems to be the best approach for treatment of keloid and hypertrophic scars.