Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in mean diameter of treatment induced effect on wheal size
研究概览
简要总结
Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.
详细描述
Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.
In addition, itch assessment at each site will be done at baseline, 30 minutes, 60 minutes and 24 hours using VAS and questionnaire.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ( ages 18-75) outpatients with diagnosis of allergic rhinoconjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive.
排除标准
- •Subjects who are unable/unwilling to undergo cessation of oral antihistamines for five days prior to testing.
- •Current use of oral steroids or other systemic immunosuppressants, including omalizumab (anti-IgE therapy) and anti-IL-5 therapy.
- •Allergic asthmatics who have current uncontrolled asthma.
研究组 & 干预措施
Placebo
Placebo cream without minocycline
干预措施: Placebos (Drug)
Minocycline Arm
Minocycline cream (1%,2%,3%)
干预措施: Minocycline Topical (Drug)
结局指标
主要结局
Change in mean diameter of treatment induced effect on wheal size
时间窗: 24 hours
Compare mean diameter of placebo associated mean wheal diameter vs. 1%, 2%, and 3% minocycline cream
次要结局
- Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo(24 hours.)
研究者
Rauno Joks, MD
Chief Division of Allergy Immunology
State University of New York - Downstate Medical Center