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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 therapeuti
• Препарат 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 therapeuti

Первичные конечные точки

• The Efficacy in terms of POSAS SCAR SCALE of Intralesional Bleomycin as compared to 5-fluorouracil (5-FU) and Triamcinolone Acetonide(TAC) for the treatment of Keloids: A Randomized Control Trial [Срок оценки: 12 weeks]
• efficacy of intralesional bleomycin and combination of triamcinolone acetonide and 5-flourouracil in treating keloids, comparing the scar reduction in accordance with the patient and observer scar (POSAS) scale in two groups. [Срок оценки: 4 months]

Критерии участия

Критерии включения

• All, patients aged 13-60 years of age, either gender enrolled for Keloid treatment under local anaesthesia.

Критерии исключения

• Allergic to bleomycin, 5-FU DIABETICS VASCULAR INSUFFICIENCY AT THE AFFECTED SITE

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• King Edward Medical University — Lahore

Публикации

• 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. PMID 35871490
• 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. PMID 31361934
• 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. PMID 27378582

Идентификаторы

NCT: NCT07201766 · 645/RC/KEMU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗