Efficacy and Safety of Intralesional Cryosurgery Alone and in Combination With Intralesional 5-fluorouracil/Triamcinolone Acetonide Injection for Treatment of Keloids: a Comparative Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Change in keloid size
研究概览
简要总结
evaluate the efficacy and safety of intralesional cryosurgery alone compared with intralesional cryosurgery combined with intralesional 5-fluorouracil and triamcinolone acetonide in the treatment of keloids.
详细描述
Keloids are abnormal scars characterized by excessive collagen deposition that extends beyond the original wound boundaries, often leading to cosmetic disfigurement, pain, pruritus, and tenderness, significantly affecting patients' quality of life . Keloid formation is influenced by genetic predisposition, skin tension, wound location, and inflammatory responses, and they are notorious for high recurrence rates, with some reports indicating recurrence in up to 50-80% of cases after treatment .
Various therapeutic modalities have been used for the management of keloids. These treatment options can be broadly classified into intralesional therapies, topical therapies, and procedural interventions.
Despite the availability of multiple treatment options, no single therapy ensures complete resolution, and recurrence remains a significant challenge in keloid management .
Intralesional corticosteroids remain the first-line therapy, reducing fibroblast proliferation, collagen synthesis, and local inflammation. Clinical studies have shown flattening of keloids in 50-70% of patients with repeated injections . Another commonly used intralesional agent is 5-fluorouracil (5-FU), an antimetabolite that inhibits fibroblast proliferation and extracellular matrix deposition, with reported improvement in 70-80% of cases . Combination therapy of corticosteroids and 5-FU has demonstrated superior efficacy compared with monotherapy.
Among procedural modalities. Intralesional (IL) cryotherapy, is a technique in which a cryogen can be applied using a cryoneedle directly into the deeper dermis of the scar to produce rapid scar freezing from the core outwards, thus all the pathological tissue will be frozen and destructed, creating a new scar without keloidal characteristics, while sparing the surface epithelium. As a monotherapy, IL cryosurgery has yielded promising clinical results in terms of volume reduction and alleviation of pain and pruritus . Marked efficacy of a single intralesional cryosurgery session has been recorded even in voluminous keloids, which is an additional major advantage compared with the repeated sessions required in classical contact cryosurgery, However, on average, no complete scar eradication is attained and scar recurrence is seen. Also, persistent hypopigmentation remains problematic in nonwhite patients . These issues raise the question whether IL cryotherapy could be used in combination with nonsurgical therapies to augment the therapeutic effect and to lower the risk of hypopigmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
"To ensure blinding, patients in the control group will receive intralesional saline injections as a placebo. Clinical and dermoscopic evaluations will be performed by two independent observers blinded to the treatment groups."
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) with clinically diagnosed keloids .
- •Keloids of size 1-10 cm in greatest dimension .
- •Keloids of at least one year duration
排除标准
- •Females who are pregnant, planning pregnancy, or lactating .
- •Hypertrophic scars .
- •Chronic kidney or liver disease (relevant for 5-FU safety) .
- •Patients with active inflammation, infection, or ulcer at or around the keloid or Lesions suspicious for malignancy .
- •Patients who received any treatment for the same keloid in the past 12 months .
- •Immunosuppressed patients or those with chronic inflammatory diseases .
研究组 & 干预措施
Cryotherapy + Saline Injection (Placebo)
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
干预措施: Intralesional Cryotherapy + Saline Injection (Procedure)
Cryotherapy + TAC/5-FU Injection
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.
干预措施: Intralesional Cryotherapy + TAC/5-FU Injection (Procedure)
结局指标
主要结局
Change in keloid size
时间窗: 12 weeks
Keloid severity will be assessed using the Vancouver Scar Scale (VSS), which evaluates vascularity, pigmentation, pliability, and height. Scores range from 0 to 13, with higher scores indicating more severe scarring. Assessment will be performed by blinded observers.
次要结局
- Patient Scar Assessment (PSAS)(up to 12 weeks)
研究者
Hadeer Ali Abouelela
MD Student / Dermatology Department
Northwest Biotherapeutics
