Impact of Fluocinonide 0,05% in Oral Lichen Planus

Sponsor

University of Catania (Other)

Overall Status

Recruiting

CT.gov ID

NCT06135805

Collaborator

(none)

Enrollment

Location

Arms

38.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Drug: Fluocinonide 0,05% oral gel Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 27, 2020

Anticipated Primary Completion Date :

Dec 19, 2023

Anticipated Study Completion Date :

Jan 3, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assessment of sings [3 months]
Assessment of sings using the Thongprasom scoring system at baseline and after 2 months

Secondary Outcome Measures

Assessment of symptoms [3 months]
Assessment of symptoms using the VAS scale at baseline and after 2 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

University of Catania

Investigators

Principal Investigator: Gaetano Isola, University of Catania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, Researcher, University of Catania

ClinicalTrials.gov Identifier:

NCT06135805

Other Study ID Numbers:

121-30

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lichen Planus, Oral

Lichen Planus

Fluocinonide

Study Results

No Results Posted as of Nov 18, 2023