A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 30% Change in Lichen Planopilaris Activity (LPPAI) Scores
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 18 years of age, and able to provide informed consent
- •Females who are post-menopausal defined, as not have menses for at least 12 months without an alternative medical cause and elevated follicle stimulating hormone in the postmenopausal range as measured during screening
- •Have active FFA that has been diagnosed on or prior to screening visit.
- •Have LPPAI score equal to or greater than 5 at screening.
- •Have evidence of eyebrow loss at baseline
- •Have evidence of hairline recession at baseline
- •Have classic presentation with frontal loss of scalp hair
- •Negative screening for tuberculosis (Quantiferon Gold, T-spot) within 3 months prior to screening or at the screening visit.
- •Agree not to have a live vaccination during the study the exception is herpes zoster vaccine
排除标准
- •Systemic treatments for FFA within 4 weeks of the baseline visit or 5 half lives whichever one is longer. (ex: finasteride, pioglitazone, hydroxychloroquine, or immunosuppressant medications, such as mycophenolate mofetil).
- •Dutasteride within the last 6 months
- •Have a LPPAI score less than 5 at screening
- •Immunocompromised and with risk factors concerning to investigator for study participation
- •Previous treatment with an oral JAK inhibitor
- •Any condition in the opinion of the investigator which would interfere with the study assessments or procedure
- •Subject is pregnant or breast feeding
- •Surgical intervention including face lifts and micro-blading on the treatment areas
- •Any intervention (facelifts micro blading) that could affect the treatment areas (i.e. scalp and eyebrows)
- •Laser or phototherapy intervention on the treatment areas
- •Have evidence of active TB or latent TB
研究组 & 干预措施
Baricitinib
All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks.
干预措施: Baricitinib 4 MG Oral Tablet (Drug)
结局指标
主要结局
30% Change in Lichen Planopilaris Activity (LPPAI) Scores
时间窗: From baseline to week 12, 24, and 36
Percentage of patients achieving 30% change in LPPAI scores. LPPAI is a numeric scale that includes key signs and symptoms of FFA and allows for statistical comparison of disease activity. It captures patient reported symptoms (pruritus, pain, burning), clinical signs (erythema, perifollicular erythema, and scale), and other disease activity features (anagen pull and spreading). The total score distributes 30% weight to symptoms, 30% to signs, 25% to anagen pull, and 15% to spreading. The scale then ranges from 0-10 where 0 is no disease and 10 is worst disease.
次要结局
- Improvement in Physician Global Assessment (PGA)(From baseline to week 12, 24, and 36)
- Change in inflammation on histology as seen on scalp biopsy(From baseline to week 12,24, and 36)
- Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale(From baseline to week 12,24, and 36)
- Improvement in Eyebrow Assessment(From baseline to week 12,24, and 36)
- Improvement in Visual Analog Scale (VAS)(From baseline to week 12,24, and 36)
研究者
Boni Elewski
Professor
University of Alabama at Birmingham