Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Keloid Scar Assessment by Patients
研究概览
简要总结
The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.
详细描述
Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Keloids size equal or major than 1 cm
- •Keloids less than 5 years old
- •Keloids in trunk
排除标准
- •Keloid with a surgical indication
- •Hypertrophic scars
- •Scars after burn wounds
- •Pregnancy
- •Lactation
- •Use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication
- •Known hypersensitivity for triamcinolone or pirfenidone
- •Severe comorbidity not controlled
- •Inflammatory acne
- •Diabetes Mellitus
- •Hypertension
- •Renal, hepatic or respiratory failure
- •Topical treatment 4 weeks before recruitment
- •Previous treatment with intralesional steroids
研究组 & 干预措施
Intralesional Triamcinolone
A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.
干预措施: Intralesional Triamcinolone (Drug)
Topical Pirfenidone
Dosage commensurate with scar surface to be treated. After washing and drying the affected area, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.
干预措施: Topical Pirfenidone (Drug)
Triamcinolone + Pirfenidone
A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Simultaneously, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.
干预措施: Triamcinolone + Pirfenidone (Drug)
结局指标
主要结局
Change in Keloid Scar Assessment by Patients
时间窗: 0 and 24 weeks
Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
Change in Keloid Scar Assessment
时间窗: 0 and 24 weeks
Assessment using the Vancouver Scar Scale (VSS)
次要结局
- Occurrence of adverse effects(Every 4 weeks after the beginning of the intervention up to 52 weeks)
- Quality of life of the patient(24 weeks)
- Recurrence defined as an increase size of the keloid scar at week 52(52 weeks)