Impact of Fluocinonide 0,05% in Oral Lichen Planus

NCT06135805 | Completed

• 1 other identifier: 121-30
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• Assessment of sings

  Assessment of sings using the Thongprasom scoring system at baseline and after 2 months

  3 months

Secondary Outcomes (1)

• Assessment of symptoms

  3 months

Study Arms (2)

Active Comparator: Fluocinonide 0,,05% oral gel

EXPERIMENTAL

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

Placebo Comparator: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fluocinonide 0,05% oral gel DRUG

Application of Fluocinonide oral gel on oral syntomatic lesions

Active Comparator: Fluocinonide 0,,05% oral gel

Placebo DRUG

Application of placebo oral gel on oral lesions

Placebo Comparator: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: August 20, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months
• Access Criteria: Pubmed

Locations

IT (1)