Intra-lesional ACE Inhibitor for Treatment of Hypertrophic Scars
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Change in Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
Hypertrophic scarring is a difficult and debilitating condition where one develops excessive scarring after full thickness injury to the skin. This is very common in full thickness burn injury. Currently, there is no reliable treatment of these scars. One of the more effective treatments available is serial intralesional injection of a steroid.
Angiotensin II is an active peptide in the body that results in vasoconstriction of the blood vessels when activated. Medications used today like angiotensin II receptor blocks and angiotensin converting enzyme inhibitors work to prevent the activation of angiotensin II and are mainly used to help control blood pressure. Previous studies in rat models have shown that angiotensin II receptor blockers can effectively reduce scar hypertrophy.
In this study, the investigators will conduct a randomized control trial with a paired split-scar design. One arm receiving the standard therapy of serial intra-lesional injections of triamcinolone acetonide (TAC) and the second arm receiving an ACE-inhibitor. The outcome will be measured using the Patient and Observer Scar Assessment Scale (POSAS), a validated assessment tool.
详细描述
Intralesional injection of corticosteroids such as triamcinolone acetonide (TAC) for treatment of hypertrophic scars are often used as first-line therapy owing to their ease of administration and relatively low cost. This medication mitigates further scar growth through increasing local vasoconstriction and simultaneously decreasing local inflammation at the site of scar hypertrophy.
Angiotensin II is an active peptide hormone which is produced by a cascade of reactions in order create its final form. Angiotensin converting enzyme (ACE) inhibitors, such as enalaprilat, competitively inhibit the enzyme that converts angiotensin I to angiotensin II. Angiotensin II receptor blockers, such as losartan, competitively inhibit the receptor. Both cause a decrease in the active form of angiotensin II and angiotensin II-induced vasoconstriction, resulting in lower blood pressure. Losartan has been demonstrated in rat models to effectively reduce the incidence of scar hypertrophy when administered post-operatively. With scar hypertrophy there is an overactivation of the wound healing cascade in both hypertrophic and keloid scars. As its vasodilative effects can be elicited without metabolism by the liver, local injection of either and ACE inhibitor or an ARB is hypothesized to effectively decrease the local effects of hypertrophy in scars.
Enalaprilat is an ACE-inhibitor that is used to treat hypertension and given in intravenous form. It is approved by Health Canada for this use. TAC is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action. It is approved by Health Canada. It is suitable for intradermal, intra-articular, and intrabursal injection.
In this study, the investigators plan to conduct a randomized control trial to determine the efficacy of intralesional injection of enalaprilat, an ACE-inhibitor, for treatment of hypertrophic scarring. Current standard of practice at the Halifax Infirmary consists of serial injections of TAC at the time of excision and then every 6 weeks for a total of three injections. The investigators plan to test this method against the injection of intralesional enalaprilat. The trial will be carried in compliance with the protocol, Canadian guidelines for Good Clinical Practice and the research ethics board of Nova Scotia Health Authority.
The investigators propose a double-blinded randomized controlled trial with a paired split-scar design to test the use of enalaprilat for intralesional injection in a hypertrophic scar. This will be compared against injection of TAC alone, the standard of care for hypertrophic scarring. The objective of this trial is improvement in the hypertrophic scar with the use of enalaprilat as measured by the Patient and Observer Scar Assessment Scale.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with scar tissue demonstrating features of hypertrophic scarring (e.g., raised, red tissue, contractures, extends beyond the boundary of the original wound)
排除标准
- •scar does not demonstrate any distinguishing features of hypertrophic scar;
- •self-reported as pregnant and/or breastfeeding;
- •documented hepatic, heart, or renal dysfunction;
- •patients with known Cushing's disease or glaucoma;
- •documented history of angioedema;
- •patients with diabetes;
- •patients being treated with any anti-hypertensive medications
- •patients under 18 years of age
研究组 & 干预措施
Intra-lesional triamcinolone acetonide + enalaprilat
This will be our intervention experiment. They will receive a single intra-lesional injection of 1.0 mL of 1.25 mg/mL of enalaprilat at 0 weeks, 6 weeks, and 12 weeks.
干预措施: Intralesional enalaprilat injection (Drug)
结局指标
主要结局
Change in Patient and Observer Scar Assessment Scale (POSAS)
时间窗: Outcomes will be measured at 0, 6-, 12-, and 52 weeks
The POSAS patient scale uses patient-reported measurements of symptoms (pain and itchiness) and signs (colour, stiffness, thickness, irregularity) to quantify the degree of the scar. Similarly, the POSAS observer scale uses measurements of scar vascularity, pigmentation, thickness, relief, pliability, and surface area in order to quantify development of scar tissue. For the observer, the maximum score is 50 and the minimum score is 5. A higher score indicates a worse outcome. For the patient, the maximum score is 60 and the minimum score is 6. A higher score indicates a worse outcome.
次要结局
未报告次要终点