The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frontal Fibrosing Alopecia Severity Score (FFASS) change
研究概览
简要总结
Frontal fibrosing alopecia (FFA) is a type of scarring hair loss that mostly affects women and causes permanent hair loss. Two medicines, hydroxychloroquine (HCQ) and methotrexate (MTX), are often used to treat FFA, but it is not yet clear which treatment works better. This study aims to compare the effects of HCQ and MTX in everyday clinical care.
Adults with FFA who choose to start either HCQ or MTX and will be followed for up to 48 weeks.
The main goal is to see how well each medicine helps reduce disease activity, measured by a tool called the Frontal Fibrosing Alopecia Severity Score (FFASS) after 6 months. At each clinic visit, participants will also complete short questionnaires about symptoms, quality of life, and general well-being.
By collecting this information, the study hopes to provide better evidence about how well HCQ and MTX work for FFA, which may help guide future treatment recommendations.
详细描述
Frontal fibrosing alopecia (FFA) is a form of primary cicatricial alopecia characterized by progressive, irreversible hair loss. It typically affects postmenopausal women. The disease presents with frontotemporal hairline recession, eyebrow loss, and perifollicular inflammation. Although the exact cause remains unclear, an autoimmune-mediated destruction of follicular stem cells is suspected.
Treatment options are limited and largely empirical. Among systemic therapies, hydroxychloroquine (HCQ) and methotrexate (MTX) are the most commonly prescribed in clinical practice. Both drugs are used off-label, and there is no consensus on their effectiveness. Existing studies are mostly retrospective or small-scale. As a result, clinical decision-making is highly variable and evidence-based guidelines are lacking.
This multicenter, prospective patient preference trial has been designed to evaluate the effectiveness of HCQ compared with MTX in adults with FFA under routine clinical care conditions.
Study procedures:
Eligible patients (≥18 years) with a confirmed diagnosis of FFA will be recruited at dermatology outpatient clinics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Diagnosis of frontal fibrosing alopecia (FFA)
- •Willing and able to provide written informed consent
- •Adequate understanding of the Dutch language
- •No known contraindications or allergies to hydroxychloroquine (HCQ) or methotrexate (MTX)
排除标准
- •Histopathological different diagnosis than FFA.
- •Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.
- •Patients who are ineligible for the HCQ arm (due to contraindications), are automatically included in the MTX arm.
- •Contraindications HCQ: retinopathy and/or maculopathy/myasthenia gravis/body weight less than 35 kg
- •- Patients who are ineligible for the MTX arm (due to contraindications), are automatically included in the HCQ arm.
研究组 & 干预措施
Hydroxychloroquine group
Intervention: hydroxychloroquine
干预措施: Hydroxychloroquine (HCQ) (Drug)
Methotrexate group
Intervention: methotrexate
干预措施: Methotrexate (MTX) (Drug)
结局指标
主要结局
Frontal Fibrosing Alopecia Severity Score (FFASS) change
时间窗: Baseline to 24 weeks
The FFASS is a validated scoring system (range 0-25) that captures extent of hairline recession, eyebrow loss, clinical signs of inflammation, and patient symptoms. The primary endpoint is the mean change in FFASS from baseline to 24 weeks, comparing the hydroxychloroquine and methotrexate cohorts.
次要结局
- Health-Related Quality of Life (HRQoL)(Baseline, Weeks 12, 24, 36, and 48)
- FFASS change over time(Baseline, Weeks 12, 24, 36, and 48)
- Adverse Events and Safety(Baseline through Week 48)
- Cost-Effectiveness and Health Economic Outcomes(Baseline and Week 24)
研究者
Rick Waalboer-Spuij, MD, PhD
Principal Investigator
Erasmus Medical Center