NCT04718311

Study on Treatment for Patients With Symptomatic Oral Lichen Planus

Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Oral lichen clinical Healing evaluation	Treatments were topically applied for 5 days

Timeline

• Start date: 2019-01-02
• Primary completion: 2020-03-05
• Completion: 2020-03-20
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: Italy