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临床试验/NCT03968562
NCT03968562Unknown2 期

Assessment of Suppression of Cutaneous Allergic Responses and Pruritus by Topical Doxycycline

State University of New York - Downstate Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
相关药物

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 Allergen Induced Wheal Diameter

研究概览

简要总结

Investigators will study the effects of topical doxycycline on cutaneous allergic early and late phase responses by determining allergen skin responses in each subject after a single application to allergen induced allergic swelling of 2% doxycycline in emollient.

详细描述

This study is a cross-sectional survey to be completed in a single consecutive two day study visit.

To assess the effect of topical doxycycline 2% emollient cream or control emollient on immediate hypersensitivity allergy skin tests responses, pruritus, and associated late phase skin swelling.

Investigators will use generic Aquaphor, a skin protectant, as the control emollient. The active ingredient in this cream is Petrolatum 42%. Inactive ingredients include ceresin, lanolin alcohol, microcrystalline wax, mineral oil, phenoxyethanol.

Adults (ages 18-75 yrs) treated at the SUNY Downstate/UHB Allergy Faculty Practice with known respiratory (allergic rhinoconjunctivitis and/or asthma), and who have previously been evaluated and are allergen skin prick test (SPT) positive to common aeroallergens will, after five days of non-use of oral antihistamine therapy, undergo limited repeat SPT with the same documented positive allergens (up to 5 allergens per subject).

  1. Allergen skin prick testing (Dermapik method) will be done on the volar surface of each forearm, with identical SPT allergens. The profile to be tested will be individualized, from 1-5- allergens, to be determined by previous skin test positive results. Volunteers for the study who have not been previously tested will also be eligible, provided they have a history of symptoms consistent with allergic rhinoconjunctivitis and/or asthma. These subjects will receive testing with a select panel of 5 mixed allergens - to include both perennial (cat, dust mite) and seasonal (tree, grass, ragweed).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

入选标准

  • Adult (ages 18-75) outpatients with diagnosis of allergic rhino-conjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive, and who may or may not have had a serum IgE level done as part of their routine evaluation.

排除标准

  • Subjects 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 with current uncontrolled asthma.
  • Pregnant women

研究组 & 干预措施

2% Doxycycline Cream in Generic Aquaphor

Active Comparator

2% Doxycycline Cream in Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration. Will perform concurrent to Placebo Comparator

干预措施: 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor (Drug)

Generic Aquaphor

Placebo Comparator

Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration. Will perform concurrent to Active Comparator.

干预措施: 2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor (Drug)

结局指标

主要结局

Change in Mean Allergen Induced Wheal Diameter

时间窗: 60 minutes

Greatest diameter millimeters and orthogonal diameter millimeters, mean of both

次要结局

未报告次要终点

研究者

发起方
State University of New York - Downstate Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rauno Joks, MD

Chief Division of Allergy Immunology

State University of New York - Downstate Medical Center

研究点 (1)

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