The Efficacy of Intralesional Bleomycin as Compared to 5-Flourouracil (5-FU) and Triamcinolone Acetonide (TAC) for the Treatment of Keloids: A Randomized Control Trial.

Summary

The goal of this clinical trial is to learn if drug bleomycin intralesionally is beneficial than intralesional 5FU and Triamcinolone Acetonide in treating Keloids. The main questions it aims to answer are: Does drug Bleomycin injected intrasleisonally lower the time duration to effectively treat the keloids in participants as compared to intralesional Triamcinolone Acetonide and 5-Flourouracil? Researchers will compare drug Bleomycin and 5FU plus Triamcinolone Acetonide and determine if bleomycin is better. Participants will: Treatment will be given in two groups by a researcher blinded of the treatment being given in each group. POSAS patient and observer scar scale will be used to assess the keloids at 0, 2, 4, 6, 8, 10, and 12 weeks and during follow ups afterwards, assessments will be carried out by another researcher who will assess the improvement on the scale of 0-no improvement, to excellent-75-100% improvement in terms of POSAS variables. Effectiveness will be indicated by 50% reduction in POSAS score from the baseline.

Timeline

Start

2025-12-02

Primary completion

2026-02-20

Completion

2026-02-28

Publications

• Background Moravej H, Forghanian A, Dadkhahfar S, Mozafari N. Intralesional bleomycin versus intralesional triamcinolone in the treatment of keloids and hypertrophic scars. Dermatol Ther. 2022 Sep;35(9):e15730. doi: 10.1111/dth.15730. Epub 2022 Aug 3.
• Background Khan HA, Sahibzada MN, Paracha MM. Comparison of the efficacy of intralesional bleomycin versus intralesional triamcinolone acetonide in the treatment of keloids. Dermatol Ther. 2019 Sep;32(5):e13036. doi: 10.1111/dth.13036. Epub 2019 Aug 8.
• Background Bijlard E, Kouwenberg CA, Timman R, Hovius SE, Busschbach JJ, Mureau MA. Burden of Keloid Disease: A Cross-sectional Health-related Quality of Life Assessment. Acta Derm Venereol. 2017 Feb 8;97(2):225-229. doi: 10.2340/00015555-2498.

Drugs

Indications