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.