Use of Topical Non-Steroidal Anti- Inflammatory to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score.
研究概览
简要总结
Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current treatments for lichen planus and lichenoid mucositis are usually directed towards reducing the symptoms.
This double-blinded cross-over placebo-controlled clinical trial is designed to measure the effectiveness of a topical NSAID (Ibuprofen suspension - 100mg/5ml) compared with a placebo in reducing pain associated with Oral Lichen Planus and Oral Lichenoid Lesions.
Exclusion criteria include:
- The occurrence of dysplasia in the histopathological specimen
- Known or suspected sensitivity to NSAID medication
- History of asthma
- History of gastrointestinal ulceration
- History of bleeding disorders
- Pregnancy
Outcome measures are self-reported pain scores at day 0, day 4 and day 7 of use of the placebo or active suspension, using a horizontal 100 mm, visual analog scale (VAS). If subjects were already on active treatment at the time of enrollment, they will be asked to discontinue for 7 days for a washout period before starting the research study.
cord their spontaneous pain level on a 0-10 VAS.
Participants will be contacted initially after the first day of the intervention to discuss any concerns or questions. Every week, reminder phone calls will be made to the subjects to fill out the forms from the investigator and to check for any side effects from the intervention.
Both the patient and the investigator will be blinded for the content of each bottle.
详细描述
A four-week randomized, double-blind, cross-over, placebo-controlled trial was planned. Ethical approval was obtained from the Institutional Review Board (IRB) at the University of Washington before the start of the study, participants agreed to participate in this study had to sign a written informed consent. The present trial was also registered (#NCT03509675). The research was conducted in accordance with the ethical principles stated in the World Medical Association's Helsinki Declaration.
A coin was flipped to decide which medication would be used first to start the randomization. Based on the coin toss, drug A was chosen for the first block of two participants. Then, block randomization was further assigned by blocks of two, alternating the drugs. The medicines were distributed in identical plastic containers, packed by an external pharmacist who was unaware of the protocol and successfully labeled as A and B containers.
During the intervention, neither investigators nor the participants knew which of the treatments they were using.
Population and Study Sample
Potential participants were screened through the Oral Medicine patient registry at the University of Washington. Prospective patients aged 18-80 were examined by the attending at the Oral Medicine Clinical Services (OMCS) faculty. All potential study participants with a clinical diagnosis of symptomatic oral lichenoid mucositis with or without a biopsy were identified. Individuals were eligible for inclusion if they met the following criteria:
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blinded crossover study
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
- •Speak English
- •Have a symptomatic form of the disease.
- •Are at least 18 years of age.
排除标准
- •Known or suspected sensitivity to non-steroidal anti-inflammatory medication
- •History of asthma
- •History of gastrointestinal ulceration
- •History of bleeding disorders
- •Use of anti-inflammatory agents in the last 24 hours
- •Use of systemic steroid medication in the last 14 days.
- •Pregnancy
研究组 & 干预措施
Placebo
Placebo suspension was compounded with the same taste as the active medication but without the active ingredient.
干预措施: Placebos (Drug)
Active ingredient
The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.
干预措施: Ibuprofen suspension 5mg/100ml (Drug)
结局指标
主要结局
Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score.
时间窗: Total pain improvement over day 0 to day 7 (summation of improvement over 7 days)
We will be looking for an improvement in symptoms through summation of the reduction in pain using a 100mm, where 0= no pain and 100= worst pain experienced Visual Analog Scale(VAS). Minimum pain level of 30mm out of 100 mm was an inclusion criteria in the study. Participants were asked to record spontaneous pain level at day 0, day 4 and at the end of day 7 timepoints for both arms/groups. Lower scores mean a better outcome.
次要结局
未报告次要终点
研究者
Stuart Taylor
Assistant Professor: Oral Medicine
University of Washington