Impact of Fluocinonide 0,05% in Oral Lichen Planus

University of Catania

Status: Completed

Conditions: Oral Lichen Planus

Treatments: Drug: Fluocinonide 0,05% oral gel; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06135805

121-30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

Active Comparator: Fluocinonide 0,,05% oral gel

Experimental group

Description:

Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month.

Treatment:

Drug: Fluocinonide 0,05% oral gel

Placebo Comparator: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo