Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Neurogenic inflammation-QOL
研究概览
简要总结
This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia.
详细描述
Primary scarring alopecias (PSAs) are poorly understood dermatologic disorders that result in permanent hair loss. Most of the scarring alopecias involve a painful course, with individuals reporting scalp pain, burning, itching, or tingling/crawling sensations that can ultimately impact physical and psychological health. There has been no study of topical neurogenic agents, such as gabapentin, to treat scarring alopecia. However topical gabapentin has been safely used in other conditions associated with chronic pain, burning, irritation, itch, or tingling, such as vulvodynia. This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia. In this study, 10 subjects with symptomatic lymphocytic-type scarring alopecia will be recruited and treated with topical gabapentin. Disease burden will be evaluated before and after 12 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, clinical assessment, and biopsies measuring levels of CGRP before and after treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults, greater than 18 years of age
- •Biopsy-proven diagnosis of primary scarring alopecia of lymphocytic inflammatory infiltrate type, indicated as one of the following conditions: lichen planopilaris, frontal fibrosing alopecia, or central centrifugal cicatricial alopecia
- •At least one persistent scalp symptom associated with inflammation: pain, burning, itch, tingling/crawling, stinging, or tenderness
- •Able to complete survey and questionnaire subjectively
- •Consents to participate in neurometer study and scalp biopsy acquisition
- •Willingness to adhere to study protocol
- •If subject is taking a neuromodulatory medication (including capsaicin cream, tricyclic antidepressants, carbamazepine, phenytoin, topiramate, oxcarbazepine, lamotrigine, morphine, Botox, etc), he or she must be a stable dose for at least 6 months prior to study enrollment
排除标准
- •Allergy or intolerance to gabapentin or the substances used in its compounding
- •Underlying disease that might be adversely affected by topical gabapentin
- •Application of topical immunomodulatory or immunosuppressive agent to the scalp in the preceding 2 weeks
- •Systemic administration of corticosteroid or other systemic treatment (i.e., methotrexate, phototherapy) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks
- •Clinical evidence of secondary skin infection
- •Individuals who have undergone scalp reduction surgery or hair transplantation
- •Asymptomatic disease
- •Immunosuppression due to disease state or use of systemic/topical biological agents (HIV, chemotherapy, immunomodulators, history of transplantation)
- •Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents)
- •Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months
- •Use of illicit drugs or opioid medications
- •Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study
- •Implantable Cardioverter Defibrillator (ICD) or pacemaker
- •Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications
研究组 & 干预措施
Topical gabapentin
gabapentin 6% solution, 1mL applied twice daily for 12 weeks
干预措施: Topical gabapentin (Drug)
结局指标
主要结局
Neurogenic inflammation-QOL
时间窗: Change from Baseline to 14 weeks
Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)
Neurogenic inflammation-Short Form (36) Health Survey
时间窗: Change from Baseline to 14 weeks
Complete Short Form (36) Health Survey Scale Scale=1-5 1 being the best and 5 being the worse
Neurogenic inflammation- Visual Analog pain Scale
时间窗: Change from Baseline to 14 weeks
Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain
次要结局
- Safety and efficacy of topical 6% gabapentin -Medication side Effects(Change from Baseline to 12 weeks)
- Safety and efficacy of topical 6% gabapentin -Blood levels(Change from Baseline to 12 weeks)
- Safety and efficacy of topical 6% gabapentin -Adverse Events(Change from Baseline to 12 weeks)