NCT04673916

Treatment Protocols for Patients With Symptomatic Oral Lichen Planus

Analysis of the Efficacy of Two Treatment Protocols for Patients With Symptomatic Oral Lichen Planus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Messina · 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 clobetasol propionate 0.05% oral 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

Forty patients were assigned (20 patients per group), through a randomized design, to receive clobetasol (clobetasol gel 0.05%), 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
• Preneoplastic Condition

Interventions

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

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-02-15
• Completion: 2020-06-25
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

1 site across 1 country: Italy