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Completed

NCT Number: NCT06135805

Impact of Fluocinonide 0,05% in 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, 95124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluocinonide 0,05% oral gel

Drug

Application of Fluocinonide oral gel on oral syntomatic lesions

Placebo

Drug

Application of placebo oral gel on oral lesions

Primary outcomes

  1. Assessment of sings

    Time frame: 3 months

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

Secondary outcomes

  1. Assessment of symptoms

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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