Evaluation of Intralesional Bleomycin and Triamcinolone Acetonide in the Treatment of Keloids: A Prospective, Randomized, Open‐Label, Comparative Study

Background Keloids are benign fibroproliferative scars resulting from dysregulated wound healing and excessive collagen deposition. Despite the availability of multiple therapeutic options, an optimal treatment strategy remains uncertain. Methods This prospective, randomized, open‐label comparative study enrolled 136 patients with clinically diagnosed keloids, who were assigned to receive either intralesional bleomycin (Group A, n = 68) or intralesional triamcinolone acetonide (Group B, n = 68). Treatments were administered at 4‐week intervals for four sessions, with follow‐up conducted 2 months after the final session. Outcomes were assessed using the Vancouver Scar Scale (VSS), and responder rates were defined as ≥ 50%, ≥ 75%, and ≥ 90% reductions in VSS. Secondary outcomes included changes in scar height, surface area, and treatment‐related adverse effects. Results Bleomycin resulted in a significantly greater mean percentage reduction in VSS than triamcinolone (72.02% vs. 58.10%; p < 0.00001). A higher proportion of patients treated with bleomycin achieved ≥ 75% improvement (36.8%, n = 25/68) than those treated with triamcinolone (14.7%, n = 10/68; p = 0.0027). Improvements in vascularity, pliability, and scar height were also significantly greater in the bleomycin group, with a mean scar height reduced to 0.8 versus 1.9 mm in the triamcinolone group ( p = 0.003). The reduction in surface area was comparable between the groups ( p = 0.850). Pain ( n = 50, 74%) and hyperpigmentation ( n = 18, 26%) were more frequently observed with bleomycin, whereas skin atrophy ( n = 16, 24%) and telangiectasia ( n = 15, 22%) were more common with triamcinolone. Conclusion Both therapies were associated with significant clinical improvement; however, bleomycin demonstrated superior efficacy in reducing scar severity and achieving higher response rates. Larger, multicenter, blinded studies with longer follow‐up periods are warranted to confirm these findings and evaluate long‐term outcomes, including recurrence rates.