Impact of Fluocinonide 0,05% in Oral Lichen Planus

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Fluocinonide 0,05% oral gel; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaetano Isola; Phone Number: 0953785652; Email: gaetano.isola@unict.it
• Study Contact Backup: Name: Rosalia Leonardi; Email: rleonardi@unict.it

Study Locations

• Italy
  • Catania, Italy, 95124
    • Recruiting
    • AOU Policlinico G. Rodolico
    • Contact: Gaetano Isola, DDS; Phone Number: 3909537800; Email: gaetano.isola@unict.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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, β-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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Comparator: Fluocinonide 0,,05% oral gel; Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month.	Drug: Fluocinonide 0,05% oral gel; Application of Fluocinonide oral gel on oral syntomatic lesions
Placebo Comparator: Placebo Comparator: Placebo; Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month.	Drug: Placebo; Application of placebo oral gel on oral lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of sings	Assessment of sings using the Thongprasom scoring system at baseline and after 2 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of symptoms	Assessment of symptoms using the VAS scale at baseline and after 2 months	3 months

Collaborators and Investigators

• Sponsor: University of Catania
• Investigators: Principal Investigator: Gaetano Isola, University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Estimated): December 19, 2023
• Study Completion (Estimated): January 3, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Fluocinonide
• Other Study ID Numbers: 121-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 3 months
• IPD Sharing Access Criteria: Pubmed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No