A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY ON EFFICACY AND SAFETY OF INTRALESIONAL INSULIN VS INTRALESIONAL TRIAMCINOLNE ACETONIDE VS INTRALESIONAL TRIAMCINOLONE ACETONIDE + 5-FLUOROURACIL FOR KELOID.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To assess the clinical efficacy of Intralesional Insulin vs Intralesional Triamcinolone acetonide vs Intralesional Triamcinolone acetonide + 5-Fluorouracil in management of keloid.
研究概览
简要总结
Keloids are benign fibroproliferative growths of dermal connective tissue that arises from a disorganized fibro-proliferative collagen response that extends beyond the original wound margins due to excessive production of extracellular matrix. Clinically, they present with raised, firm, erythematous scars extending beyond the original wound margin, causing functional impairment, disfigurement, pain, and pruritus. Current treatment modalities—intralesional corticosteroids, 5-FU, cryotherapy, lasers, and surgical excision—have variable efficacy and high recurrence rates. This is a prospective, comparative, randomized study on efficacy, safety and tolerability of Intralesional Insulin vs Intralesional Triamcinolone Acetonide vs Intralesional Triamcinolone Acetonide + 5- Fluorouracil for keloid. The study will be conducted at a tertiary care hospital. The patients will be divided in groups of 3 by simple randomization. Each group will have 22 patients each. Group A will include patients who will be given intralesional short acting insulin at a dose of 10 IU/cm3 at an interval of 4 weeks for 4 months. Group B will include patients who will be given intralesional Injection Triamcinolone Acetonide 40 mg/mL diluted to 20 mg/ml using local anaesthetic and administered at a dose of 0.1 mL/cm3, at an interval of 4 weeks for 4 months.Group C will include patients who will be given intralesional injection of 50 mg/mL 5-Fluorouracil + 40 mg/mL Triamcinolone acetonide in ratio of 9:1 at a dose of 0.1 mL/cm3 , at an interval of 4 weeks for 4 months. After completion of last visit, the patients will be observed for 3 months period to assess progress, recurrence or any long-term side effects of treatment given. Thus, the study aims to study the efficacy, safety and tolerability of Intralesional Insulin vs Intralesional Triamcinolone Acetonide vs Intralesional Triamcinolone Acetonide + 5- Fluorouracil for keloid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- ••Age 18 to 60 years •Both male and female •Clinical diagnosis of keloid equal to more than 3 months duration •Keloid of size between 1 to 10 cubic centimeters.
- ••Willing to provide informed consent and comply with follow-up.
排除标准
- •Age less than 18 or more than 60 years -Keloid of size more than 10 cubic centimeters.
- •Diabetic patients -Individuals receiving insulin or oral hypoglycemic drugs -Pregnant or lactating female -Immunocompromised patients -Patients on immunosuppressive drugs or systemic corticosteroids within last 3 months -Patients with evidence of bone marrow suppression including leukopenia,thrombocytopenia or anemia -Active infection or ulceration over lesion -Recent keloid treatment within last 8 weeks -Keloids on mucosa, eyelids or sites unsafe for injection -Coagulopathy or bleeding disorder -Hypersensitivity to study drugs -Individuals unwilling or unable to comply with the follow up schedule.
结局指标
主要结局
To assess the clinical efficacy of Intralesional Insulin vs Intralesional Triamcinolone acetonide vs Intralesional Triamcinolone acetonide + 5-Fluorouracil in management of keloid.
时间窗: Baseline, 4, 8, 12 and 16 weeks
次要结局
- To study safety and tolerability of Intralesional Insulin vs Intralesional Triamcinolone Acetonide vs Intralesional Triamcinolone Acetonide + 5- Fluorouracil in management of keloid.
研究者
Dr Jashanpreet Kaur
Shri Bhausaheb Hire Government Medical College