Study on Treatment for Patients With Symptomatic Oral Lichen Planus

University of Catania

Status: Completed

Conditions: Lichen Planus, Oral

Treatments: Drug: Oral lichen clinical Healing evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04718311

121/120

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Tacrolimus treatment

Active Comparator group

Description:

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).

Treatment:

Drug: Oral lichen clinical Healing evaluation

Anti-inflammatory mouthwash

Placebo Comparator group

Description:

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.

Treatment:

Drug: Oral lichen clinical Healing evaluation