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.
NCT ID: NCT07201766
Last Updated: 2025-11-25
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
104 participants
INTERVENTIONAL
2025-12-02
2026-02-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
Exclusion Criteria:
Allergic to bleomycin, 5-FU DIABETICS VASCULAR INSUFFICIENCY AT THE AFFECTED SITE
TREATMENT
SINGLE
Study Groups
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The Efficacy of 5-fluorouracil (5-FU) and Triamcinolone Acetonide in treatment of keloids
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.
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.
The Efficacy of Intralesional Bleomycinin treatment of keloids
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
13 Years
60 Years
ALL
No
Sponsors
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King Edward Medical University
OTHER
Responsible Party
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Shumaila Dogar
Consultant
Locations
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King Edward Medical University
Lahore, , Pakistan
Countries
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Central Contacts
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References
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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.
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.
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.
Other Identifiers
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645/RC/KEMU
Identifier Type: -
Identifier Source: org_study_id
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