Study on Treatment for Patients With Symptomatic Oral Lichen Planus

NCT ID: NCT04718311

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-03-20

Brief Summary

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

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.

Conditions

Lichen Planus, Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tacrolimus treatment

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).

Group Type: ACTIVE_COMPARATOR

Oral lichen clinical Healing evaluation

Intervention Type: DRUG

Treatments were topically applied for 5 days

Anti-inflammatory mouthwash

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.

Group Type: PLACEBO_COMPARATOR

Oral lichen clinical Healing evaluation

Intervention Type: DRUG

Treatments were topically applied for 5 days

Interventions

Oral lichen clinical Healing evaluation

Treatments were topically applied for 5 days

Intervention Type: DRUG

Other Intervention Names

Topical drug tacrolimus or mouthwash application

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

University of Catania

Catania, CT, Italy

Countries

Italy

Other Identifiers

121/120

Identifier Type: -

Identifier Source: org_study_id