Study on Treatment for Patients With Symptomatic Oral Lichen Planus

Study Overview
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Brief Summary
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The primary objective of this study was to compare the therapeutic efficacy of Tacrolimus gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

Detailed Description
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Thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%, umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.

Official Title
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Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus

Conditions
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Lichen Planus, Oral

Intervention / Treatment
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* Drug: Oral lichen clinical Healing evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years; clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria; presence of symptoms related to OLP. Exclusion Criteria: presence of systemic conditions that may have affected the study results; state of pregnancy or breastfeeding; histological signs of dysplasia; drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.); treatment of OLP in the six months prior to the start of the programme; presence of extraoral lesions (genital, skin and other) history of previous immunodeficiency or HIV seropositivity; previous allogeneic bone marrow transplantation; presence of systemic lupus erythematosus or other autoimmune diseases.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus treatment<br>Apply a small amount (about 1 teaspoon) of medication to the lesions, twice a day after brushing the teeth, with a soft bristle toothbrush or with a finger (covered with a well-fitting glove). | Drug: Oral lichen clinical Healing evaluation<br>* Treatments were topically applied for 5 days<br>* Other names: Topical drug tacrolimus or mouthwash application;|
| Placebo Comparator: Anti-inflammatory mouthwash<br>Anti-inflammatory mouthwash In patients of the anti-inflammatory group, the mouthwash was used pure and without dilution at a dosage of 20 ml 3 times a day, immediately after normal daily oral hygiene was prescribed. It contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins. Patients were instructed to rinse for at least 5 minutes over the entire oral mucosa, with particular emphasis on the regions where the lesions are located. | Drug: Oral lichen clinical Healing evaluation<br>* Treatments were topically applied for 5 days<br>* Other names: Topical drug tacrolimus or mouthwash application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Mucosal healing | Patients clinically were evaluated using the scale used by Thongprasom et al. as reference. This gives a score that varies from 0 to 5, using a millimetre reference: 0, in the absence of lesions; 1, in the presence of hyperkeratosis streaks; 2, in the presence of an atrophic area less than 1 mm2; 3, in the presence of an atrophic area greater than 1 mm2; 4, in the presence of an erosive area less than 1 mm2; 5, in the presence of an erosive area greater than 1 mm2. In the presence of multiple injuries, the value has been calculated by summing the values of each injury. | 180 days |