NCT07201766

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 13 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. An informed, written consent will be taken from the patients. Clinical data including demographic data will be recorded. Patients will be randomly divided into two groups by using random allocation software 2.0. Group A will be given 1ml if 0.9ml/22.5mg (25mg/ml) of 5-FU with 0.1 ml/4mg (40mg/ml) of Triamcinolone Acetonide, intralesionally 1cm apart, as 0.1- 0.2ml/cm2 with max dose of 5ml per session and repeat after every 2 weeks. Group B will be given injection Bleomycin 1.5 IU /ml (15 units vial dilution in 10ml Normal saline) 1 ml of this 1cm apart intralesionally as 0.1- 0.2ml/cm2 with max dose of 5ml per session and repeat after 2 weeks. 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. All the data will be noted on a specially designed pro forma.

Conditions

• Keloids Scars

Interventions

Type	Name	Description
DRUG	intralesional bleomycin	The role of intralesional bleomycin for the treatment of keloids needs further establishment in terms of effective concentration, number of sessions and post treatment ulceration or/and hypopigmentation. Additionally, its comparison to the commonly used and proven, more effective combination than intralesional steroid alone i-e 5-FU in combination with the intralesional steroid, need also be done so that if found affective will be able to deal with the pathological scar as a 1 st line therapeutic drug. With a strong study design and an adequate sample size, and particularly in a specialized tertiary care clinical setup, Our study, seeks to get over the aforementioned limitations, and will delineates the appropriate guidelines for the management of these pathological scars, and suggest option with the best outcomes, as well as lesser side effects and recurrence rates.
DRUG	5-flourouracil and triamcinolone acetonide	The role of intralesional bleomycin for the treatment of keloids needs further establishment in terms of effective concentration, number of sessions and post treatment ulceration or/and hypopigmentation. Additionally, its comparison to the commonly used and proven, more effective combination than intralesional steroid alone i-e 5-FU in combination with the intralesional steroid, need also be done so that if found affective will be able to deal with the pathological scar as a 1 st line therapeutic drug. With a strong study design and an adequate sample size, and particularly in a specialized tertiary care clinical setup, Our study, seeks to get over the aforementioned limitations, and will delineates the appropriate guidelines for the management of these pathological scars, and suggest option with the best outcomes, as well as lesser side effects and recurrence rates.

Timeline

• Start date: 2025-12-02
• Primary completion: 2026-02-20
• Completion: 2026-02-28
• First posted: 2025-10-01
• Last updated: 2025-11-25

Locations

1 site across 1 country: Pakistan