Oral Lichen Planus
Conditions
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.
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.
Interventions
DRUGFluocinonide 0,05% oral gel
Application of Fluocinonide oral gel on oral syntomatic lesions
DRUGPlacebo
Application of placebo oral gel on oral lesions
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of sings | 3 months | Assessment of sings using the Thongprasom scoring system at baseline and after 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of symptoms | 3 months | Assessment of symptoms using the VAS scale at baseline and after 2 months |
Countries
Italy
Outcome results
None listed