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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Comparator: Placebo | Placebo Comparator | Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinonide 0,05% oral gel | Drug | Application of Fluocinonide oral gel on oral syntomatic lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of sings | Assessment of sings using the Thongprasom scoring system at baseline and after 2 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of symptoms | Assessment of symptoms using the VAS scale at baseline and after 2 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Isola | University of Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Catania | 95124 | Italy |
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3 months
Pubmed
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| Placebo | Drug | Application of placebo oral gel on oral lesions |
|
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |