Efficacy and Safety of add-on Topical Timolol in the Management of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor-induced Paronychia: A Prospective Randomized Open-labelled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding)
研究概览
简要总结
This study would assess the clinical efficacy of add-on topical timolol 0.5% gel to betamethasone valerate 0.1% for the treatment of EGFR-TKI induced paronychia. Eligible patients, who develop paronychia (affecting fingernails, toenails or both), will be included in this study. They will be randomized in 1:1 ratio using computer-generated randomization list to receive either combination of topical timolol 0.5% gel and betamethasone valerate 0.1% lotion application twice daily or betamethasone valerate 0.1% lotion application twice daily. Patients in timolol combination treatment group will receive topical timolol 0.5% gel twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% lotion twice daily with occlsuion for 1 month. Patients in routine arm would receive the management according to routine clinical practice, including prescription of betamethasone valerate 0.1% lotion twice daily for 1 month with occlusion. For patients who do not have paronychia completely resolved after 4 weeks, the treatment assigned will be continued for another 4 to 8 weeks , up to 12 weeks to see the effect.
详细描述
The aim of this study ist o assess the clinical efficacy of add-on topical timolol 0.5% gel to betamethasone valerate 0.1% for the treatment of EGFR-TKI induced paronychia.
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
- None
盲法说明
This is an open-label trial, and no one will be masked
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
- •Aged 18 years or above, either males or females.
- •Received EGFR-TKI, namely gefitinib, erlotinib, afatinib, osimertinib, amivantamab, dacomitinib and mobocertinib.
- •Paronychia (fingernails, toenails, or both) as an adverse event from EGFR-TKI use.
- •Written informed consent obtained from patient.
排除标准
- •Patients who are allergic to, or contraindicated to topical timolol use.
- •Pregnant women or nursing mother.
- •Non-consenting patients.
研究组 & 干预措施
Timolol combination treatment
Patients will received topical timolol 0.5% eye drops (liquid form) twice daily with occlusion (i.e. covered with adhesive badge) and betamethasone valerate 0.1% cream twice daily with occlsuion for 1 month
干预措施: Topical Timolol (Drug)
Routine arm
Patients in routine arm would receive the management according to routine clinical practice, including prescription of betamethasone valerate 0.1% cream twice daily for 1 month with occlusion.
干预措施: Betamethasone Valerate (Drug)
结局指标
主要结局
The difference in the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding)
时间窗: From baseline to month 3
The primary outcome of this study is the proportion of patients achieved complete response (disappearance of the lesion, absent pain, and/or bleeding) on topical timolol 0.5% eye drops as compared to betamethasone valerate 0.1% cream.
次要结局
- The proportion of patients achieved complete or partial response(From baseline to month 3)
- Change in chronic paronychia severity index scale with treatment(From baseline to month 3)
- Lack of response as well as proportion of patients with reduced severity of paronychia(From baseline to month 3)
- The improvement of paronychia by 4 point scale(From baseline to month 3)
- Change in severity of pain by Visual Analog Scale(From baseline to month 3)
研究者
Kwok Wang Chun
Clinical Assistant Professor
Queen Mary Hospital, Hong Kong