Lichen PlanusPhase 2NCT02850601
Dexamethasone Solution for the Treatment of Oral Lichen Planus
A Phase 2 study testing Dexamethasone in people with Lichen Planus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this single center, 4-week, open label randomized, phase II study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen planus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 20 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years and older.
- Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).
Who cannot join
- Patients already on topical or systemic steroids.
- Inability to comply with study instructions.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- VAS sensitivity score < 7.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Lichen Planus
The objective of this single center, 4-week, open label randomized, phase II study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen planus.
Read the detailed description
Potentially eligible subjects will be screened by one of the investigators by asking patients to rate their worst oral pain or pain score (0-10) over the previous week (see Appendix). Those answering with at least a score of "7" (1/10) and that meet all other eligibility requirements (see Section 3) will be eligible for enrollment. All patients will sign informed consent for study participation. Each study visit is anticipated to take approximately 45 minutes.
Treatment will be administered on an outpatient basis. Study medication will be prescribed by authorized study staff physicians at no expense for the patient.
Subjects will be evaluated clinically at baseline before starting treatment and at the end of the four-week period, for a total of two visits. Comprehensive subjective and objective data will be collected and intraoral photographs will be obtained. Oral mucosal disease will be evaluated using both patient reported (questions/visual analog scales) and clinician assessed measures.
Subjects will be prescribed compound dexamethasone 0.5mg/5ml solution in Mucolox™ (ARM A) or dexamethasone 0.5mg/5ml solution only (ARM B). All subjects will also receive a prescription for fluconazole 200 mg tablets once-a-week as prophylactic antifungal therapy. Any subjects that are already taking an antifungal oral medication at the time of the study enrollment will continue their prescribed medication and will not need to take the additional weekly fluconazole dose. Subjects will return for evaluation after four weeks at which time the study end-points will be assessed.
If there is worsening of oral lichen planus that requires initiation of new immunomodulatory medications (systemic or topical), patients will remain on treatment, but will be regarded as unevaluable for the primary endpoint.
- Conditions
- Lichen Planus
- Being tested
- Dexamethasone
- Keywords
- Oral lichen planus, Dexamethasone solution
- Medical subject headings
- Lichen Planus, Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron Elixir
Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone solution | Experimental | Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks Receives: Drug: Dexamethasone |
| Dexamethasone solution in Mucolox™ | Active comparator | Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Sensitivity
Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline.
Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.
Measured: 4 weeks after the start of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start7 Feb 2017
- Primary completion19 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herve Y. Sroussi, D.M.D.,Ph.D., Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850601
- Sponsor's protocol ID
- 2016D003018
- Status last verified
- May 2021
- First submitted
- 26 Jul 2016
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT02850601
- Acronym / sponsor ID
- 2016D003018
- Conditions
- Lichen Planus
- Keywords
- Oral lichen planus, Dexamethasone solution
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this single center, 4-week, open label randomized, phase II study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen planus.
Detailed description
Potentially eligible subjects will be screened by one of the investigators by asking patients to rate their worst oral pain or pain score (0-10) over the previous week (see Appendix). Those answering with at least a score of "7" (1/10) and that meet all other eligibility requirements (see Section 3) will be eligible for enrollment. All patients will sign informed consent for study participation. Each study visit is anticipated to take approximately 45 minutes.
Treatment will be administered on an outpatient basis. Study medication will be prescribed by authorized study staff physicians at no expense for the patient.
Subjects will be evaluated clinically at baseline before starting treatment and at the end of the four-week period, for a total of two visits. Comprehensive subjective and objective data will be collected and intraoral photographs will be obtained. Oral mucosal disease will be evaluated using both patient reported (questions/visual analog scales) and clinician assessed measures.
Subjects will be prescribed compound dexamethasone 0.5mg/5ml solution in Mucolox™ (ARM A) or dexamethasone 0.5mg/5ml solution only (ARM B). All subjects will also receive a prescription for fluconazole 200 mg tablets once-a-week as prophylactic antifungal therapy. Any subjects that are already taking an antifungal oral medication at the time of the study enrollment will continue their prescribed medication and will not need to take the additional weekly fluconazole dose. Subjects will return for evaluation after four weeks at which time the study end-points will be assessed.
If there is worsening of oral lichen planus that requires initiation of new immunomodulatory medications (systemic or topical), patients will remain on treatment, but will be regarded as unevaluable for the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone solution | Experimental | Drug: DexamethasoneDexamethasone 0.5 mg/mL, 5ml TID for 4 weeks |
| Dexamethasone solution in Mucolox™ | Active comparator | Drug: DexamethasoneCompounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years and older.
- Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).
Key exclusion criteria (4 listed)
- Patients already on topical or systemic steroids.
- Inability to comply with study instructions.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- VAS sensitivity score < 7.
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 |
|---|---|---|
| DexamethasoneAlso: Decadron ElixirDexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate | Drug | Dexamethasone solution, Dexamethasone solution in Mucolox™ |
Primary outcome
Change in Oral Sensitivity
Time frame: 4 weeks after the start of the trial
Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline. Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
Lichen Penis Planus
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dexamethasone in people with Lichen Planus, run by Brigham and Women's Hospital at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 14 Jun 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Oral Sensitivity (time frame: 4 weeks after the start of the trial). 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 14 Jun 2021.