Oral Lichen PlanusPhase 2EMPATIANCT07100613
Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
A Phase 2 study testing Clobetasol Patch, Clobetasol + Resveratrol Patch and Clobetasol in Orabase in people with Oral Lichen Planus and Oral Lichen Planus Related Stress, run by University of Palermo at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus, Oral Lichen Planus Related Stress, Oral Mucosal Disease
- What is being tested?
- Clobetasol Patch, Clobetasol + Resveratrol Patch and Clobetasol in Orabase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2024to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Clinical suspicion of Oral Lichen Planus (OLP).
- Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria).
- Absence of epithelial dysplasia.
- Ability to understand and sign informed consent.
Who cannot join
- Previous diagnosis or treatment for OLP.
- Use of topical or systemic corticosteroids in the last 4 weeks.
- Use of medications known to cause lichenoid reactions.
- History of allergic reactions to dental materials (e.g., amalgam).
- Hematological disorders or immunodeficiencies.
- Pregnancy or breastfeeding.
- Current use of immunosuppressive therapies.
- Inability or unwillingness to comply with study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Palermo
Palermo, Italy
University of Palermo, 091 238 93011
About this study
Official title: Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:
Does the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?
Read more
Researchers will compare:
A patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base
Participants will:
Apply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience
Read the detailed description
Oral Lichen Planus (OLP) is a chronic inflammatory condition affecting the oral mucosa, often causing painful lesions, burning sensations, and impaired quality of life. Current treatments primarily rely on high-potency topical corticosteroids, such as clobetasol propionate. However, conventional formulations like ointments or pastes may be difficult to apply, poorly retained in the oral cavity, and associated with limited bioavailability or side effects.
This clinical trial investigates the efficacy of a novel mucoadhesive drug delivery system in the form of a patch. The patch is designed to adhere to the oral mucosa, releasing the active compounds in a controlled and prolonged manner. Two types of patches are tested: one containing clobetasol propionate alone and one containing a combination of clobetasol and resveratrol, a natural polyphenol known for its anti-inflammatory and immunomodulatory properties.
The study is a triple-blind, randomized, controlled clinical trial conducted on adult patients with a confirmed histological diagnosis of symptomatic OLP. Participants are randomly assigned to one of three arms:
Arm 1: Patch with clobetasol propionate Arm 2: Patch with clobetasol propionate and resveratrol Arm 3 (Control): Clobetasol 0.05% in an orabase-type adhesive paste Treatments are applied over a 30-day period following a standardized schedule. Clinical evaluations take place at baseline, 15 days, and 30 days, and include photographic documentation, symptom scoring with the Visual Analog Scale (VAS), and clinical severity assessment using the Thongprasom score. In addition, participants complete the Oral Health Impact Profile-14 (OHIP-14) questionnaire to evaluate changes in oral-health-related quality of life.
Structural changes in the mucosa are monitored using Optical Coherence Tomography (OCT), a non-invasive imaging technique that allows real-time visualization of tissue layers, providing objective information on epithelial healing and inflammation.
The primary outcomes are reduction in pain and burning symptoms, improvement of lesion severity, and increased quality of life. Secondary outcomes include patient compliance and OCT-based structural improvement. This study aims to offer a more effective, better tolerated, and innovative therapeutic approach for managing oral lichen planus.
- Being tested
- Clobetasol Patch, Clobetasol + Resveratrol Patch, Clobetasol in Orabase
- Keywords
- mucoadhesive patch, oral lichen planus, clobetasol, resveratrol, drug delivery system, Optical coherence tomography, Ora pain
- 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.
Clobetasol PatchDrug
Also called Mucoadhesive Clobetasol Patch
A mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion.
Clobetasol + Resveratrol PatchDrug
Also called Mucoadhesive Patch with Clobetasol and Resveratrol
A mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion.
Clobetasol in OrabaseDrug
Also called Clobetasol 0.05% Orabase Paste
Clobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion.
| Study group | Role | What they receive |
|---|---|---|
| Clobetasol Patch | Experimental | Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05%. The patch is applied directly to the symptomatic oral lesion once daily for 30 days, following oral hygiene. No food or drink is allowed for 30 minutes after application. The patch is self-dissolving. Receives: Drug: Clobetasol Patch |
| Clobetasol + Resveratrol Patch | Experimental | Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. The patch is applied once daily for 30 days on the symptomatic oral lesion. It is self-adhering and dissolves without removal. No food or drink is allowed for 30 minutes after application. Receives: Drug: Clobetasol + Resveratrol Patch |
| Clobetasol in Orabase | Active comparator | Participants will receive clobetasol propionate 0.05% in an orabase-type adhesive paste, applied once daily for 30 days after oral hygiene. Application is made directly to the lesion. No food or drink is allowed for 30 minutes after application. Receives: Drug: Clobetasol in Orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Intensity (Pain/Burning)
Patient-reported pain and burning intensity will be measured using the 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse symptoms.
Measured: Baseline and Day 30
Change in Clinical Severity of Lesions
Clinical improvement will be assessed using the Thongprasom clinical scoring system (score range 0-5, where 0 = no lesion and 5 = severe erosive lesion). Higher scores indicate worse lesion severity. The outcome will measure the change from baseline to day 30.
Measured: Baseline and Day 30
Secondary outcomes (3)
Change in Oral Health-Related Quality of Life
Evaluated using the Oral Health Impact Profile-14 (OHIP-14) questionnaire (range 0-56, with higher scores indicating worse quality of life).
Measured: Baseline and Day 30
Compliance with Treatment
Adherence to the patch protocol, measured as the number of daily applications recorded in participant diaries.
Measured: Day 15 and Day 30
Epithelial Structural Improvement (OCT Imaging)
Changes in mucosal architecture will be assessed using Optical Coherence Tomography (OCT). Improvement is defined as reduction in epithelial discontinuities and inflammatory patterns.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start4 Sep 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description: Triple-arm, parallel assignment model with 1:1:1 randomization. Each participant is randomly assigned to one of three intervention groups receiving either: (1) a mucoadhesive patch with clobetasol, (2) a mucoadhesive patch with clobetasol and resveratrol, or (3) clobetasol 0.05% in an orabase-type paste.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Panzarella, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100613
- Sponsor's protocol ID
- EMPATIA
- Acronym
- EMPATIA
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
- ClinicalTrials.gov ID
- NCT07100613
- Acronym / sponsor ID
- EMPATIA / EMPATIA
- Keywords
- mucoadhesive patch, oral lichen planus, clobetasol, resveratrol, drug delivery system, Optical coherence tomography, Ora pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 3 Aug 2025 (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.
The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:
Does the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?
Researchers will compare:
A patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base
Participants will:
Apply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience
Detailed description
Oral Lichen Planus (OLP) is a chronic inflammatory condition affecting the oral mucosa, often causing painful lesions, burning sensations, and impaired quality of life. Current treatments primarily rely on high-potency topical corticosteroids, such as clobetasol propionate. However, conventional formulations like ointments or pastes may be difficult to apply, poorly retained in the oral cavity, and associated with limited bioavailability or side effects.
This clinical trial investigates the efficacy of a novel mucoadhesive drug delivery system in the form of a patch. The patch is designed to adhere to the oral mucosa, releasing the active compounds in a controlled and prolonged manner. Two types of patches are tested: one containing clobetasol propionate alone and one containing a combination of clobetasol and resveratrol, a natural polyphenol known for its anti-inflammatory and immunomodulatory properties.
The study is a triple-blind, randomized, controlled clinical trial conducted on adult patients with a confirmed histological diagnosis of symptomatic OLP. Participants are randomly assigned to one of three arms:
Arm 1: Patch with clobetasol propionate Arm 2: Patch with clobetasol propionate and resveratrol Arm 3 (Control): Clobetasol 0.05% in an orabase-type adhesive paste Treatments are applied over a 30-day period following a standardized schedule. Clinical evaluations take place at baseline, 15 days, and 30 days, and include photographic documentation, symptom scoring with the Visual Analog Scale (VAS), and clinical severity assessment using the Thongprasom score. In addition, participants complete the Oral Health Impact Profile-14 (OHIP-14) questionnaire to evaluate changes in oral-health-related quality of life.
Structural changes in the mucosa are monitored using Optical Coherence Tomography (OCT), a non-invasive imaging technique that allows real-time visualization of tissue layers, providing objective information on epithelial healing and inflammation.
The primary outcomes are reduction in pain and burning symptoms, improvement of lesion severity, and increased quality of life. Secondary outcomes include patient compliance and OCT-based structural improvement. This study aims to offer a more effective, better tolerated, and innovative therapeutic approach for managing oral lichen planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Model Description: Triple-arm, parallel assignment model with 1:1:1 randomization. Each participant is randomly assigned to one of three intervention groups receiving either: (1) a mucoadhesive patch with clobetasol, (2) a mucoadhesive patch with clobetasol and resveratrol, or (3) clobetasol 0.05% in an orabase-type paste.
| Arm | Type | Receives |
|---|---|---|
| Clobetasol Patch | Experimental | Drug: Clobetasol PatchParticipants will receive a mucoadhesive patch containing clobetasol propionate 0.05%. The patch is applied directly to the symptomatic oral lesion once daily for 30 days, following oral hygiene. No food or drink is allowed for 30 minutes after application. The patch is self-dissolving. |
| Clobetasol + Resveratrol Patch | Experimental | Drug: Clobetasol + Resveratrol PatchParticipants will receive a mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. The patch is applied once daily for 30 days on the symptomatic oral lesion. It is self-adhering and dissolves without removal. No food or drink is allowed for 30 minutes after application. |
| Clobetasol in Orabase | Active comparator | Drug: Clobetasol in OrabaseParticipants will receive clobetasol propionate 0.05% in an orabase-type adhesive paste, applied once daily for 30 days after oral hygiene. Application is made directly to the lesion. No food or drink is allowed for 30 minutes after application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Clinical suspicion of Oral Lichen Planus (OLP).
- Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria).
- Absence of epithelial dysplasia.
- Ability to understand and sign informed consent.
Key exclusion criteria (8 listed)
- Previous diagnosis or treatment for OLP.
- Use of topical or systemic corticosteroids in the last 4 weeks.
- Use of medications known to cause lichenoid reactions.
- History of allergic reactions to dental materials (e.g., amalgam).
- Hematological disorders or immunodeficiencies.
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 |
|---|---|---|
| Clobetasol PatchAlso: Mucoadhesive Clobetasol PatchA mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion. | Drug | Clobetasol Patch |
| Clobetasol + Resveratrol PatchAlso: Mucoadhesive Patch with Clobetasol and ResveratrolA mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion. | Drug | Clobetasol + Resveratrol Patch |
| Clobetasol in OrabaseAlso: Clobetasol 0.05% Orabase PasteClobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion. | Drug | Clobetasol in Orabase |
Primary outcome
Change in Symptom Intensity (Pain/Burning)
Time frame: Baseline and Day 30
Patient-reported pain and burning intensity will be measured using the 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse symptoms.
Change in Clinical Severity of Lesions
Time frame: Baseline and Day 30
Clinical improvement will be assessed using the Thongprasom clinical scoring system (score range 0-5, where 0 = no lesion and 5 = severe erosive lesion). Higher scores indicate worse lesion severity. The outcome will measure the change from baseline to day 30.
3 secondary outcomes
Change in Oral Health-Related Quality of Life
Time frame: Baseline and Day 30
Compliance with Treatment
Time frame: Day 15 and Day 30
Epithelial Structural Improvement (OCT Imaging)
Time frame: Baseline and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clobetasol Patch, Clobetasol + Resveratrol Patch and Clobetasol in Orabase in people with Oral Lichen Planus and Oral Lichen Planus Related Stress, run by University of Palermo 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Panzarella (091 6554612, vera.panzarella@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Intensity (Pain/Burning) (time frame: Baseline and Day 30). The study lists 2 primary outcomes in all. 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 3 Aug 2025.