Study on Treatment for Patients With Symptomatic Oral Lichen Planus

Lichen Planus, Oral Clinical Trial

Official title:

Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718311
• Other study ID #: 121/120
• Status: Completed
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: January 2021
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 20, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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, ß-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.

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral

Intervention

Drug:
• Oral lichen clinical Healing evaluation
Treatments were topically applied for 5 days

Locations

Country	Name	City	State
Italy	University of Catania	Catania	CT

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Mucosal healing	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.	180 days