Clinical trial NCT06327620: Treatment Of Oral Lichen Planus
Official title: A Novel Alternative Treatment Of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lichen Planus
Keywords: lichen planus
Treatment
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.

The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.

Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.

Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.

The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition.

Detailed description: This clinical study aims to explore a novel alternative treatment for oral lichen planus (OLP) utilizing Daivobet ointment, a combination of calcipotriol and betamethasone. The protocol is designed to provide in-depth technical information on patient selection, treatment procedures, clinical assessments, and statistical analyses, ensuring a comprehensive understanding of the study's methodology.

Patient Selection:

Fifteen patients aged 30-60 with bilateral intra-oral erosive lichen planus symptoms will be recruited from the department of Oral Medicine and Diagnosis at the Faculty of Dentistry, Kafr Elsheikh University. Participants with a history of unresponsiveness to current therapies will undergo histopathological confirmation through incisional biopsy.

Inclusion Criteria:

Presence of bilateral oral erosive lichen planus lesions. Clinical and histopathological diagnosis of oral lichen planus based on a modified definition of the World Health Organization (WHO).

Exclusion Criteria:

Histological signs of dysplasia. Use of drugs possibly causing a lichenoid reaction and lesions in contact with dental amalgam restorations.

Any topical or systemic medications used in the treatment of oral lichen planus within four weeks before the study.

Patients with a history of hypersensitivity to the drug used in the current study.

Clinical Assessment:

Patients will be instructed to topically apply Daivobet ointment on one side and a topical steroid on the other side three times daily for four weeks. Clinical evaluations will be conducted at the study's onset, with baseline parameters recorded, and reassessed at the end of the second and fourth weeks.

Objective Response:

Lesions of oral lichen planus will be scored using a scaled tongue blade, categorizing them from 0 (no lesion) to 5 (erosive area \>1cm2). Quantitative measurements will be calculated using a transparent grid to obtain the total area of the lesion.

Subjective Response:

Discomfort scores will be recorded on a visual analog scale ranging from 0 to 3, and a questionnaire documenting potential adverse effects will be completed. Patients will rank the severity of their discomfort.

Biopsy Specimens and Laboratory Investigations:

Incisional biopsy specimens will be obtained under local anesthesia, incorporating both clinically normal and diseased tissues. The specimens will undergo routine histologic study, confirming the diagnosis through formalin-fixed, paraffin-embedded, hematoxylin-and eosin-stained sections.

Statistical Analysis:

Data analysis will be performed using SPSS version 16 for Windows. The normality of data will be assessed using Shapiro-Wilk tests. Descriptive statistics, median, minimum, and maximum tests will be employed to describe the measure of central tendency and dispersion in each group. Groups will be compared using the Mann-Whitney U test. For non-parametric continuous variables, the degree of improvement will be calculated, and the mean value for the degree of improvement used to compare between groups. The significance level will be set at P ≤ 0.05.

Patient Registry Procedures:

Quality assurance plan addressing data validation, registry procedures, site monitoring, and auditing.

Data checks to compare entered data against predefined rules for range or consistency.

Source data verification assessing the accuracy, completeness, or representativeness of registry data by comparing it to external sources.

Data dictionary containing detailed descriptions of each variable, including source, coding information, and normal ranges.

Standard Operating Procedures covering registry operations and analysis activities, including patient recruitment, data collection, management, analysis, reporting for adverse events, and change management.

Sample size assessment specifying the number of participants or participant years necessary to demonstrate an effect.

Plan for missing data addressing situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing due to data inconsistency or out-of-range results.

Statistical analysis plan describing the analytical principles and techniques employed to address the primary and secondary objectives, as specified in the study protocol or plan.

Eligibility criteria: Inclusion Criteria:

Age between 30-60 years. Clinical signs and symptoms of bilateral intra-oral erosive lichen planus. History of unresponsiveness to currently available therapy. Histopathological confirmation by incisional biopsy. Willingness to topically apply Daivobet ointment in one side and topical steroid in the other side three times daily for 4 weeks.

Exclusion Criteria:

* Histological signs of dysplasia. Use of drugs possibly causing a lichenoid reaction. Lesions in contact with dental amalgam restorations. Any topical or systemic medications used in the treatment of oral lichen planus within four weeks before the study.

History of hypersensitivity to the drug used in the current study.

Primary outcomes:
measure: Clinical Improvement of Oral Lichen Planus Lesions
timeFrame: End of the second and fourth weeks of treatment.
Secondary outcomes:
measure: Objective Response Score
timeFrame: End of the second and fourth weeks of treatment
measure: Subjective Response Score
timeFrame: Start of the study and at the end of the second and fourth weeks of treatment.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University, Faculty of Dentistry
state: Dakahlia
Study officials:
References: