NCT05330572 Clinical and Molecular Correlates of Response to First Line Treatment in Lichen Planus
| NCT ID | NCT05330572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aberdeen |
| Condition | Lichen Planus, Oral |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2022-02-07 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Dr Karolin Hijazi
PRINCIPAL INVESTIGATOR
University of Aberdeen
Frequently Asked Questions
Who can join the NCT05330572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lichen Planus, Oral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05330572 currently recruiting?
Yes, NCT05330572 is actively recruiting participants. Contact the research team at k.hijazi@abdn.ac.uk for enrollment information.
Where is the NCT05330572 trial being conducted?
This trial is being conducted at Aberdeen, United Kingdom, Aberdeen, United Kingdom.
Who is sponsoring the NCT05330572 clinical trial?
NCT05330572 is sponsored by University of Aberdeen. The principal investigator is Dr Karolin Hijazi at University of Aberdeen. The trial plans to enroll 110 participants.