Clinical and Molecular Correlates of Response to First Line Treatment in Lichen Planus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Identification of host related factors associated with poor response to topical steroid therapy in patients with lichen planus.
研究概览
简要总结
Lichen planus is a common inflammatory (swelling and pain of tissue) disease in the general population that affects mostly the mouth although skin and genital areas can also be affected. It can cause considerable discomfort during activities such as eating, talking and tooth brushing and may impair sexual function with an overall deleterious impact on quality of life. There is also increased evidence of cancer in a subtype of lichen planus. Therefore, treatment is essential in these patients to control the symptoms and improve the quality of life.
Locally applied steroids are the first line medicines used in the treatment of patients with lichen planus. This medicine can only control the symptoms, but cannot cure the disease. In addition, this treatment cannot be effective in all patients with lichen planus. This may be attributed to differences in host factors, mouth bacteria and individual host responses to bacteria. The exact cause of this disease is also unknown. New studies have shown changes in the balance of mouth bacteria and host responses to bacteria in patients with lichen planus. So the main purpose of our study is to identify clinical(age, gender, related medical conditions, oral health and the presence of deleterious habits like smoking and alcohol consumption), molecular(analysis of oral microbes and immune markers) and histological factors (change within tissue) associated with poor response in lichen planus patients undergoing treatment with locally applied steroid medicines. Overall, knowledge of these factors associated with disease progression is sparse, which limits progress in the realm of development of novel and personalised treatment strategies. In this study, we explore the individual and combined role of different markers in lichen planus for improving diagnosis, predicting disease progression and treatment effectiveness.
详细描述
PARTICIPANT SELECTION AND ENROLMENT
IDENTIFYING PARTICIPANTS All participants will be selected from attendants of the Oral & Maxillofacial Unit, Women's Day Clinic and Aberdeen Dental School in the Foresterhill Campus. The research team will identify eligible participants for the study by screening through review of their electronic records. Caldicott Guardian approval will be sought for Sreedevi P.U to gain direct access to patient clinical records for screening purposes. Patients diagnosed with oral or oral and vulvovaginal lichen planus will be recruited into the study, only following biopsy confirmation. The diagnosis of lichen planus will be made on the basis of accepted clinical and histopathological findings, to meet the eligibility criteria, patients must be undergoing topical steroid therapy as a part of their management plan for lichen planus.
SCREENING FOR ELIGIBILITY Patients attending routine clinics will be screened for eligibility through review of their electronic records. Here, we emphasise that no study data will be recorded from participant's medical/dental records, until we have a written informed consent from them. Eligibility of patients will be checked for predefined inclusion/exclusion criteria by reviewing clinical and histopathological records of patients that have been diagnosed with lichen planus by the clinical research team.
CONSENTING PARTICIPANTS
Potentially eligible patients will be contacted through a research study information pack sent by post. The research study information pack will include: an invitation letter, a Patient Information Sheet (PIS), a return slip and pre-paid envelope for the patient to notify the research team of whether or not they wish to participate. If the patient is interested in taking part, they will be contacted by telephone by the research team to arrange a visit at a dedicated research study session. At this point, written informed consent will be obtained from potentially eligible patients after having a verbal discussion about the nature of the study and answering any questions the patient may have. Informed consent from patients with oral lichen planus will be obtained by Dr Sreedevi P.U and the research nurse named in this application will be involved in obtaining consent from patients with vulvovaginal disease. Patients will be consented for the following aspects:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients aged more than 18 years, with confirmed histopathological diagnosis of lichen planus and undergoing topical steroid therapy.
- •Participants who have the capacity to consent.
- •Participants who show a willingness to attend an initial appointment and a follow-up post-treatment appointment.
排除标准
- •Patients on systemic steroids and other immunosuppressive agents for the treatment of lichen planus
- •Cases of graft versus host disease or those suffering from other systemic inflammatory conditions mimicking lichen planus (e.g. connective tissue disease).
- •Pregnant and lactating participants.
- •Inability to consent.
结局指标
主要结局
Identification of host related factors associated with poor response to topical steroid therapy in patients with lichen planus.
时间窗: change in disease severity score of lichen planus from baseline (start of topical steroid treatment) to completion of topical steroid therapy( 2 months after the first visit)
Correlation between the host related factors (clinical factors) and change from baseline in lichen planus disease severity score at 2 months will be assessed.
Determination of microbiome characteristics predictive of response to treatment.
时间窗: change in disease severity score of lichen planus from baseline (start of topical steroid treatment) to completion of topical steroid therapy( 2 months after the first visit)
Correlation between oral microbiota and change from baseline in lichen planus disease severity score at 2 months will be assessed.
Identification of inflammatory/immune markers associated with poor response to topical steroid therapy in patients with lichen planus.
时间窗: change in disease severity score of lichen planus from baseline (start of topical steroid treatment) to completion of topical steroid therapy( 2 months after the first visit)
Correlation between the inflammatory/immune markers in saliva or serum and change from baseline in lichen planus disease severity score at 2 months will be assessed.
Identification of histopathological morphological markers associated with poor response to topical steroid therapy in patients with lichen planus.
时间窗: change in disease severity score of lichen planus from baseline (start of topical steroid treatment) to completion of topical steroid therapy( 2 months after the first visit)
Quantification of histopathological morphological markers will be determined by analysing histopathological images of oral lichen planus using software applications ImageJ and QuPath. Correlation between these factors and change from baseline in lichen planus disease severity score at 2 months will be assessed.
次要结局
未报告次要终点