Impact of Fluocinonide 0,05% in Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:

Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135805
• Other study ID #: 121-30
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: January 3, 2024

Study information

• Verified date: November 2023
• Source: University of Catania
• Contact: Gaetano Isola
• Phone: 0953785652
• Email: gaetano.isola[@]unict.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.

Description:

A double-blind placebo-controlled study was conducted to evaluate the clinical efficacy of Fluocinonide 0.05% oral gel and determine the statistical significance of outcome variables. 20 patients with Oral Lichen Planus were divided by a randomization system, into two groups: case group treated with Fluocinonide 0.05% oral gel and applied to oral lesions 2 times a day for 1 month and a placebo group as a control group; with 2 months of follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 3, 2024
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical and histologic diagnosis of Lichen Planus Orale;
• Presence of symptoms related to Lichen Planus Orale;
• Clinical follow-up period of at least 12 weeks;
• Acceptance of informed consent

Exclusion Criteria:

• State of pregnancy or lactation; h
• Histologic signs of dysplasia;
• Medications that induce a lichenoid response (ACE inhibitors, ß-blockers, etc.);
• Presence of amalgam fillings in the vicinity of lesions;
• Treatment of oral lichen in the previous 6 months from the start of the program;
• Presence of extraoral lesions (genital, skin, etc.);
• Diabetes being treated with oral hypoglycemic drugs;
• History of previous immunodeficiency;
• HIV seropositivity;
• Previous allogeneic bone marrow transplantation;
• Diagnosis of LES or other autoimmune disease

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Fluocinonide 0,05% oral gel
Application of Fluocinonide oral gel on oral syntomatic lesions
• Placebo
Application of placebo oral gel on oral lesions

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of sings	Assessment of sings using the Thongprasom scoring system at baseline and after 2 months	3 months
Secondary	Assessment of symptoms	Assessment of symptoms using the VAS scale at baseline and after 2 months	3 months