Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Peak Itch Intensity Between the Vehicle and Active Treatments During Non-histaminergic Itch Induction
研究概览
简要总结
Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.
详细描述
This will be a single-blinded, vehicle-controlled randomized study in healthy controls to test the efficacy of the topical gel formulation with three differing concentrations of acetaminophen (APAP) for itch relief. To detect medium effects of the treatments with a given α of 0.5 and an error probability of 0.05, with a power of 0.95, the number of participants needed is 36 (10 within post hoc pairwise comparisons).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects must be between 18 and 50 years of age.
- •Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
- •No history of chronic itch or pain.
- •Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
- •Must abstain from the use of moisturizers on the arms 24 hours before study visits.
排除标准
- •Individuals under 18 or over 50 years of age.
- •Inability to complete the required measures.
- •The presence of an itchy skin disease.
- •Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
- •Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
- •Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
- •Use of emollients on the arms a week prior to the study and throughout the study.
- •Known allergies to acetaminophen and cowhage.
- •Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
- •Currently incarcerated.
研究组 & 干预措施
Topical 5% acetaminophen gel
Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.
干预措施: Acetaminophen (Drug)
Topical 2.5% acetaminophen gel
Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.
干预措施: Acetaminophen (Drug)
Topical 1% acetaminophen gel
Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.
干预措施: Acetaminophen (Drug)
Topical vehicle gel
Topical vehile gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.
干预措施: Carbomer 980 (Drug)
结局指标
主要结局
Peak Itch Intensity Between the Vehicle and Active Treatments During Non-histaminergic Itch Induction
时间窗: 10 minutes
Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after non-histaminergic itch induction (cowhage). Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 10 was weighted with "most itch imaginable".
Peak Itch Intensity Between the Vehicle and Active Treatments During Histaminergic Itch Induction
时间窗: 10 minutes
Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after histaminergic itch induction. Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 10 was weighted with "most itch imaginable".
次要结局
- Thermal Threshold Detection (Heat Pain)(3 minutes)
研究者
Gil Yosipovitch
Professor
University of Miami