Frontlight ResearchEarly access
CompletedNo phase
Impact of Fluocinonide 0,05% in Oral Lichen Planus
Key facts
- Who runs it
- University of Catania
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 47 people enrolled
- Started
- 20 Aug 2023
- Ended
- 28 Feb 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Fluocinonide 0,05% oral gel
- Placebo
- Record updated
- 19 September 2024
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Medications that induce a lichenoid response (ACE inhibitors, β-blockers, etc.)
- Treatment of oral lichen in the previous 6 months from the start of the program
- Diabetes being treated with oral hypoglycemic drugs
- History of previous immunodeficiency
- Previous allogeneic bone marrow transplantation
- HIV seropositivity
- Diagnosis of LES or other autoimmune disease
- State of pregnancy or lactation; h
- Histologic signs of dysplasia
- Presence of amalgam fillings in the vicinity of lesions
- Presence of extraoral lesions (genital, skin, etc.)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Active Comparator: Fluocinonide 0,,05% oral gelTreatment being tested
Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month.
Treatment: Fluocinonide 0,05% oral gel
- Placebo Comparator: PlaceboPlacebo, for comparison
Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month.
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus
- Record updated
- 19 September 2024