Study on Treatment for Patients With Symptomatic Oral Lichen Planus

• ClinicalTrials.gov Identifier: NCT04718311
• Recruitment Status: Completed
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Sponsor: University of Catania
• Information provided by (Responsible Party): Gaetano Isola, University of Catania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lichen Planus, Oral	Drug: Oral lichen clinical Healing evaluation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus
• Actual Study Start Date: January 2, 2019
• Actual Primary Completion Date: March 5, 2020
• Actual Study Completion Date: March 20, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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).	Drug: Oral lichen clinical Healing evaluation; Treatments were topically applied for 5 days; Other Name: Topical drug tacrolimus or mouthwash application
Placebo Comparator: 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.	Drug: Oral lichen clinical Healing evaluation; Treatments were topically applied for 5 days; Other Name: Topical drug tacrolimus or mouthwash application

Outcome Measures

Primary Outcome Measures :

1. Clinical Mucosal healing [ Time Frame: 180 days ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Italy

University of Catania

Catania, CT, Italy, 95124

Sponsors and Collaborators

University of Catania

Investigators

• Principal Investigator: Gaetano Isola; Università degli Studi di Catania

More Information

• Responsible Party: Gaetano Isola, Researcher, University of Catania
• ClinicalTrials.gov Identifier: NCT04718311
• Other Study ID Numbers: 121/120
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Sharing results
• Supporting Materials: Study Protocol
• Time Frame: 1 year
• Access Criteria: pubmed

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lichen Planus, Oral; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases; Tacrolimus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action