Oral Erosive Lichen PlanusPhase 1/2NCT06591884
Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
A Phase 1/2 study testing Tacrolimus modified-release and tacrolimus ointment 0.1% in people with Oral Erosive Lichen Planus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are: Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Erosive Lichen Planus
- What is being tested?
- Tacrolimus modified-release and tacrolimus ointment 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2024to Dec 2028
- Phase
- Phase 1/2
- 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
- individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the American Academy of Oral and Maxillofacial Pathology
Who cannot join
- History of oral cancer;
- history of allergic reactions to tacrolimus or any other component of the formulas;
- history of organ transplant or have a systemic condition that induces significant immunosuppression;
- be pregnant or lactating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Erick S Pedraça, DDS, MsC contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Fernanda Visioli, DDS, PhD, +55 51 3308-5011, fvisioli@hcpa.edu.br
Erick S Pedraça, DDS, MsC
About this study
Official title: Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus - a Randomized Clinical Trial
The goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are:
- Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment?
- Which tacrolimus formulation can keep participants free of lesions for longer periods?
Read more
Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective.
Participants will:
- Apply one of the proposed tacrolimus formulations twice a day for 1 month.
- Visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.
- Conditions
- Oral Erosive Lichen Planus
- Being tested
- Tacrolimus modified-release, tacrolimus ointment 0.1%
- Keywords
- Oral Lichen Planus, Tacrolimus
- 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.
Tacrolimus modified-releaseDrug
0.08% tacrolimus nanoencapsulated aqueous solution spray
tacrolimus ointment 0.1%Drug
0.1% free tacrolimus commercial ointment
| Study group | Role | What they receive |
|---|---|---|
| 0.08% tacrolimus nanoencapsulated aqueous solution spray | Experimental | tacrolimus modified-release Receives: Drug: Tacrolimus modified-release |
| 0.1% free tacrolimus commercial ointment | Active comparator | Not described Receives: Drug: tacrolimus ointment 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Disease Severity Score (ODSS) - 50%
Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days).
ODSS score ranges from 0 to 106, lower score mean a better outcome.
Measured: 30 days
VAS (visual analogical score) pain score - 50%
number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days).
VAS score ranges from 0 to 10, lower score mean a better outcome.
Measured: 30 days
Secondary outcomes (3)
OHIP-14 quality of life score
the percentage and absolute reduction in OHIP-14 scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2).
OHIP-14 score ranges from 0 to 56, lower score mean a better outcome.
Measured: 15-90 days
Beck scale scores (anxiety levels)
The percentage and absolute reduction in Beck scale score in both groups at mid-treatment and end of treatment (15 and 30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2).
OHIP-14 score ranges from 0 to 63, lower score mean a better outcome.
Measured: 15-90 days
hedonic scale satisfaction scores
Comparison of hedonic scale scores of satisfaction reported by the participants in regards of treatment received in both groups at the end of treatment (30 days) and at the 30 and 60-day follow-ups after treatment completion (follow-up 1 and follow-up 2).
Hedonic scale satisfaction score ranges from 0 to 9, higher score mean a better outcome.
Measured: 30-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Erosive Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernanda Visioli, DDS, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591884
- Sponsor's protocol ID
- 2023-0566
- Other IDs
- 76823524.3.1001.5327
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06591884
- Acronym / sponsor ID
- 2023-0566
- Conditions
- Oral Erosive Lichen Planus
- Keywords
- Oral Lichen Planus, Tacrolimus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (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 assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are:
- Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment?
- Which tacrolimus formulation can keep participants free of lesions for longer periods?
Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective.
Participants will:
- Apply one of the proposed tacrolimus formulations twice a day for 1 month.
- Visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.08% tacrolimus nanoencapsulated aqueous solution spray | Experimental | Drug: Tacrolimus modified-releasetacrolimus modified-release |
| 0.1% free tacrolimus commercial ointment | Active comparator | Drug: tacrolimus ointment 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the American Academy of Oral and Maxillofacial Pathology
Key exclusion criteria (4 listed)
- History of oral cancer;
- history of allergic reactions to tacrolimus or any other component of the formulas;
- history of organ transplant or have a systemic condition that induces significant immunosuppression;
- be pregnant or lactating.
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 |
|---|---|---|
| Tacrolimus modified-release0.08% tacrolimus nanoencapsulated aqueous solution spray | Drug | 0.08% tacrolimus nanoencapsulated aqueous solution spray |
| tacrolimus ointment 0.1%0.1% free tacrolimus commercial ointment | Drug | 0.1% free tacrolimus commercial ointment |
Primary outcome
Oral Disease Severity Score (ODSS) - 50%
Time frame: 30 days
Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days). ODSS score ranges from 0 to 106, lower score mean a better outcome.
VAS (visual analogical score) pain score - 50%
Time frame: 30 days
number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days). VAS score ranges from 0 to 10, lower score mean a better outcome.
3 secondary outcomes
OHIP-14 quality of life score
Time frame: 15-90 days
Beck scale scores (anxiety levels)
Time frame: 15-90 days
hedonic scale satisfaction scores
Time frame: 30-90 days
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 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Erick S Pedraça, DDS, MsC contact
Fernanda Visioli, DDS, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tacrolimus modified-release and tacrolimus ointment 0.1% in people with Oral Erosive Lichen Planus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 4 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 2 Oct 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Fernanda Visioli, DDS, PhD (+55 51 3308-5011, fvisioli@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Disease Severity Score (ODSS) - 50% (time frame: 30 days). 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 2 Oct 2024.