Clinical and Molecular Correlates of Response to First Line Treatment in Lichen Planus

NCT05330572 | Recruiting DMC

• 1 other identifier: 2-064-21
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

Lichen Planus, Oral; Lichen Planus of Vulva

Keywords

oral lichen planus, vulvovaginal lichen planus

Outcome Measures

Primary Outcomes (4)

• Identification of host related factors associated with poor response to topical steroid therapy in patients with lichen planus.

  Correlation between the host related factors (clinical factors) and change from baseline in lichen planus disease severity score at 2 months will be assessed.

  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)

• Identification of inflammatory/immune markers associated with poor response to topical steroid therapy in patients with lichen planus.

  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.

  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)

• Determination of microbiome characteristics predictive of response to treatment.

  Correlation between oral microbiota and change from baseline in lichen planus disease severity score at 2 months will be assessed.

  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)

• Identification of histopathological morphological markers associated with poor response to topical steroid therapy in patients with lichen planus.

  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.

  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)

Study Arms (2)

Oral lichen planus

No interventions were administered to this group of patients as a part of the study.

Other: No interventions were administered to the patients as a part of this study.

Oro-vulvovaginal lichen planus

No interventions were administered to this group of patients as a part of the study.

Other: No interventions were administered to the patients as a part of this study.

Interventions

No interventions were administered to the patients as a part of this study. OTHER

No interventions were administered to the patients as a part of this study. Patients who were under topical steroid regime as a part of their management plan for lichen planus will be enrolled on the study. Details of prescribed topical steroid regime for lichen planus: type of corticosteroid, formulation, frequency of application, duration of treatment will be recorded.

Oral lichen planus; Oro-vulvovaginal lichen planus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants will be selected from attendants of the Oral \& Maxillofacial Unit, Women's Day Clinic and Aberdeen Dental School in the Foresterhill Campus. Patients diagnosed with oral or 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 who have been advised to use topical steroid therapy as a part of their management plan for lichen planus.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (2)

University of Aberdeen

Aberdeen, Aberdeen, Scotland, AB24 3FX, United Kingdom

ENROLLING BY INVITATION

Aberdeen Dental School

Aberdeen, AB25 2ZR, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Saliva * Oral mucosal swab * Venous blood sample * Vulvo-vaginal swab (where applicable) * Cervico-vaginal lavage (where applicable) All the above samples will be stored in media suitable for microbiological and immunological analysis. They will be either stored on ice for immediate processing or stored at -20° for the later analysis at the Institute of Medical Sciences, University of Aberdeen.

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr Karolin Hijazi

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Karolin Hijazi

CONTACT

01224555153; k.hijazi@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: February 7, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)