Back to resultsImpact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus
Primary Purpose
Oral Lichen Planus
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Clobetasol Topical Gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus
Eligibility Criteria
Inclusion Criteria: The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis. Exclusion Criteria: 1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.
Sites / Locations
- AOU Policlinico G. Rodolico
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Clobetasol propionate 0,05% gel
Placebo
Arm Description
Patients were treated with a topic gel of clobetasol propionate 0,05%
Patients were treated with a topic placebo gel control
Outcomes
Primary Outcome Measures
miRNAs GCF levels
The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)
Secondary Outcome Measures
OLP disease severity scores
The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05818618
Brief Title
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus
Official Title
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).
Detailed Description
A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables.
At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The main aim of the study is to analyze the impact of topical clobetasol on gingival crevicular fluid miRNAs expression in subjects affected by oral lichen planus.
Masking
ParticipantInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clobetasol propionate 0,05% gel
Arm Type
Active Comparator
Arm Description
Patients were treated with a topic gel of clobetasol propionate 0,05%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients were treated with a topic placebo gel control
Intervention Type
Drug
Intervention Name(s)
Clobetasol Topical Gel
Intervention Description
Topic Clobetasol gel applied locally on OLP lesions.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral gel applied locally on OLP lesions.
Primary Outcome Measure Information:
Title
miRNAs GCF levels
Description
The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
OLP disease severity scores
Description
The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis.
Exclusion Criteria:
1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
University of Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol
IPD Sharing Time Frame
5 months
IPD Sharing Access Criteria
Pubmed
Learn more about this trial
Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus
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