Impact of Fluocinonide 0,05% in Oral Lichen Planus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.

NCT03509675

Oral Lichen Planus Oral Lichenoid Mucositis Oral Lichenoid Reaction

COMPLETED PHASE2/PHASE3

Study on Treatment for Patients With Symptomatic Oral Lichen Planus

NCT04718311

Lichen Planus, Oral

COMPLETED NA

Treatment Protocols for Patients With Symptomatic Oral Lichen Planus

NCT04673916

Lichen Planus, Oral Preneoplastic Condition

COMPLETED NA

Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus

NCT05818618

Oral Lichen Planus

COMPLETED NA

Efficacy of Elidel Cream on Erosive Oral Lichen Planus

NCT00130572

Lichen Planus, Oral

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Lichen Planus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Fluocinonide 0,05% oral gel

Intervention Type DRUG

Application of Fluocinonide oral gel on oral syntomatic lesions

Placebo Comparator: Placebo

Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Application of placebo oral gel on oral lesions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluocinonide 0,05% oral gel

Application of Fluocinonide oral gel on oral syntomatic lesions

Intervention Type DRUG

Placebo

Application of placebo oral gel on oral lesions

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes