Nickel Desensitization Using Topical Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in contact dermatitis response to nickel allergen at 5 weeks after topical desensitization
研究概览
简要总结
Nickel contact dermatitis (eczema) is one of the most common allergic conditions affecting the skin. This is a study looking at potentially desensitizing nickel-allergic patients to their allergy using anti-inflammatory ointments applied to the skin (arm). Application of these ointments (ie. modified Vitamin D) has been shown to increase specific immune cells (T regulatory cells), which play a role in preventing immune activation and subsequently inflammation. The investigators propose use of topical anti-inflammatory agents (corticosteroids, modified Vitamin D, or both) may desensitize patients with nickel allergy.
详细描述
- Purpose: To evaluate whether topical anti-inflammatory ointments (calcipotriol, betamethasone dipropionate, or a combination of both) can decrease sensitivity to nickel in known nickel allergic patients. Optional blood samples will be part of the protocol to measure immune responses.
- Hypothesis: Use of these topical agents will prevent sensitization to nickel sulfate upon re-exposure.
- Justification: Currently, no cure can yet be offered to nickel sensitive patients. Standard treatment only involves avoiding nickel-containing products. However, this is not always easily achieved depending on patient awareness and environmental exposures. Topical desensitization has not yet been explored in patients with pre-established contact allergy. This research will be placebo-controlled with Vaseline petroleum jelly to compare reactions to nickel in those treated with anti-inflammatory ointments.
- Objectives: a) To evaluate the use of topical anti-inflammatory agents and its role in desensitizing known nickel allergic patients to nickel. b) To measure immune cell responses to nickel allergen from a blood sample taken before and after topical anti-inflammatory application.
- Research Method: Randomized, double-blinded, placebo-controlled, proof of principle study. Subjects meeting inclusion and exclusion criteria with known nickel sensitivity will be recruited into the study. Those who consent will undergo 3 sets of nickel patch testing: At week 1 to confirm nickel allergic status, week 3 to induce tolerance by patch testing at the site of topical ointment application, and finally at week 5 to test for desensitization. (Week 2 is self-application with topical ointment; Week 4 is a rest week).
- Statistical Analysis: a) Primary end-point: Clinical responses measured by standard patch testing scores will be documented and photographed for comparison. b) Secondary end-point: Levels of T regulatory cell responses before and after topical treatment. c) Planned sample size: 24 patients. Given that this is a proof-of-principle study, the investigators are choosing to study a small sample size to detect any differences amongst treatment arms, if any. A larger-scale, adequately-powered study would be needed to detect any statistical significance.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Patients have had a diagnosis of nickel allergy determined by patch testing
排除标准
- •Treatment with immunomodulating medications concurrently or in the previous one month
- •Active skin disease, particularly to the site of application (forearms)
- •Hypersensitivity to calcipotriol, corticosteroids, or vehicle
- •Previous anaphylactic reactions to nickel allergen
- •Pregnancy or breast-feeding
研究组 & 干预措施
Calcipotriol ointment
干预措施: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone (Drug)
Betamethasone dipropionate ointment
干预措施: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone (Drug)
Calcipotriol and betamethasone ointment
干预措施: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone (Drug)
Vaseline Petroleum Jelly
干预措施: Calcipotriol, Betamethasone, Calcipotriol & Betamethasone (Drug)
结局指标
主要结局
Change in contact dermatitis response to nickel allergen at 5 weeks after topical desensitization
时间窗: All study subjects will be evaluated after each patch test session (weeks 1, 3, 5). The final outcome to assess for desensitization will be evaluated at week 5.
Erythema, induration, blistering of the skin will be noted. The standardized Likert scale (0-3+) will be used as follows: 1. + Weak (non-vesicular) reaction: erythema, infiltration, possibly papules 2. ++ Strong (edematous or vesicular) reaction 3. +++ Extreme (spreading, bullous or ulcerative) reaction * Negative reaction
次要结局
- Change in immune cell profile of patients 5 weeks after nickel desensitization(All consenting subjects will have baseline blood drawn at week 0 and again at week 5 to compare any differences in immune cells (ie. T cells).)