Oral Lichen PlanusNCT06135805
Impact of Fluocinonide 0,05% in Oral Lichen Planus
A study testing Fluocinonide 0,05% oral gel in people with Oral Lichen Planus, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Fluocinonide 0,05% oral gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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.);
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of 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.
Read the 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.
- Conditions
- Oral Lichen Planus
- Being tested
- Fluocinonide 0,05% oral gel, Placebo
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinonide 0,05% oral gelDrug
Application of Fluocinonide oral gel on oral syntomatic lesions
PlaceboDrug
Application of placebo oral gel on oral lesions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluocinonide 0,05% oral gel |
| Placebo Comparator: Placebo | Placebo comparator | Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of sings
Assessment of sings using the Thongprasom scoring system at baseline and after 2 months
Measured: 3 months
Secondary outcomes (1)
Assessment of symptoms
Assessment of symptoms using the VAS scale at baseline and after 2 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Aug 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135805
- Sponsor's protocol ID
- 121-30
- Status last verified
- Sep 2024
- First submitted
- 13 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT06135805
- Acronym / sponsor ID
- 121-30
- Conditions
- Oral Lichen Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Fluocinonide 0,,05% oral gel | Experimental | Drug: Fluocinonide 0,05% oral gelPatients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month. |
| Placebo Comparator: Placebo | Placebo comparator | Drug: PlaceboPatients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluocinonide 0,05% oral gelApplication of Fluocinonide oral gel on oral syntomatic lesions | Drug | Active Comparator: Fluocinonide 0,,05% oral gel |
| PlaceboApplication of placebo oral gel on oral lesions | Drug | Placebo Comparator: Placebo |
Primary outcome
Assessment of sings
Time frame: 3 months
Assessment of sings using the Thongprasom scoring system at baseline and after 2 months
1 secondary outcome
Assessment of symptoms
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
Related trials for Oral Lichen Planus
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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Isola principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluocinonide 0,05% oral gel in people with Oral Lichen Planus, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of sings (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.