Oral Lichen PlanusPhase 2NCT00111072
Dexamethasone to Treat Oral Lichen Planus
A Phase 2 study testing dexamethasone 0.01% solution in people with Oral Lichen Planus, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain associated with oral lichen planus, a chronic disease that causes painful ulcers inside the mouth. The cause of lichen planus not known, but it may be related to an allergic or immune reaction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- dexamethasone 0.01% solution
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Mar 2006
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy confirmed symptomatic oral lichen planus. World Health Organization histological criteria (12) in combination with a compatible clinical appearance will be used for diagnosis.
- No current treatment with immunomodulatory agents. A one-month washout period will be required prior to enrollment if patients are taking immunomodulatory agents. Prior treatment with topical steroids will be allowed provided the presence of symptomatic lesions.
- Age greater than 12 years old. Lichen planus is very rare in patients younger than 40 years old. Patients must rinse and spit the medication rather than swallow it. Oral rinses such as topical fluorides are not recommended for young children.
- Patients of both sexes and all racial and ethnic groups will be eligible.
- Symptomatic lichen planus with a score of at least 35 mm on a visual analog scale for pain.
- Oral lichen planus score of at least 3 on the lichen planus severity scale.
Who cannot join
- Unable to undergo oral biopsy for diagnosis.
- Asymptomatic lichen planus with no ulcerated or erythematous oral lesions.
- Treatment with immunomodulatory agents within 1 month of the randomization.
- Hepatitis C infection.
- Documented hypersensitivity to dexamethasone.
- Pregnancy or lactation.
- Poorly controlled diabetes.
- Inability or unwillingness to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Dexamethasone 0.01% Solution for the Treatment of Oral Lichen Planus
This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain associated with oral lichen planus, a chronic disease that causes painful ulcers inside the mouth. The cause of lichen planus not known, but it may be related to an allergic or immune reaction. This study will examine what causes the disease, the pain associated with it, its impact on patients' lives and the use of dexamethasone to treat it.
Patients 12 or older with severe oral lichen planus may be eligible for this study. Candidates are screened with blood tests and a biopsy to confirm the diagnosis and provide tissues for research purposes. For the biopsy, two small circles of tissue, each about 4 mm (1/5 inch) across, are surgically removed.
Read more
Participants are randomly assigned to rinse their mouth with either a dexamethasone solution or placebo (a rinse with no active ingredient) four times a day for 4 weeks. During this period they may not use any oral or topical pain or anti-inflammatory medications except diphenhydramine 12.5 mg/5 ml (a topical numbing medicine) and Tylenol, both which are provided by the study.
Patients come to the NIH Clinical Center for three 1-hour visits (once every two weeks) and once more 4 weeks after the study medications are stopped. At the first three visits patients submit a pain diary in which they have recorded information on pain levels, and they are checked for any medication side effects. On the third visit (the last day they take the study drug) they are also tested for adrenal suppression that may have resulted from taking the steroid rinse. For this test they are given an injection of a drug called synacthen and after 1 hour, a blood sample is drawn. Patients return for a final visit 1 month later to determine if their disease returns or improves after the medication is stopped.
Read the detailed description
This is a study of pain, oral function and salivary biomarkers in oral lichen planus.
The primary objective of the study is to determine the efficacy of dexamethasone rinse in reducing pain in patients with oral lichen planus. Secondary objectives are to evaluate a novel scoring system of severity of lichen planus, assess the changes in salivary biomarkers associated with the treatment, assess the impact of oral lichen planus on the quality of life using the SF-36 instrument and the Oral Health Impact Profile (OHIP-14).
This is a double-blind parallel group design with 20 patients in each arm. Our primary outcome measure will be change in the visual analog scale that assesses pain. We will consider a decrease of 30 mm as clinically significant. Secondary outcomes will include reduction of oral symptoms as measured by the OHIP-14, amount of topical analgesic used, improvement in quality of life scores, and the severity of lesions as assessed with two scales.
A new oral lichen planus scoring system will be evaluated for validity, reliability and sensitivity to change. This system will quantify the severity and amount of oral lichen planus lesions on a scale of 0 to 66. Validation of this scale is needed for future studies of oral lichen planus. The validity and sensitivity to change will be assessed by correlation of the scores with patient based outcomes as well as global scale. Inter- and intra-rater reliability will also be tested.
The principal study interventions will be dexamethasone 0.01% oral rinse or identical in appearance and taste placebo rinse. Additional allowed interventions will be standard oral topical analgesic rinse and acetaminophen on an as needed basis. Diagnostic and research evaluations will include complete history and oral and general physical examination, laboratory investigations, saliva collection, and oral mucosal biopsy. The interventional period of the trial will be 4 weeks.
- Conditions
- Oral Lichen Planus
- Being tested
- dexamethasone 0.01% solution
- Keywords
- Mucosal Disease, Topical Steroids, Salivary Diagnostics, Oral Pain, Quality of Life Indicators, Oral Lichen Planus
- 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.
dexamethasone 0.01% solutionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2005 (estimated)
- Study startMay 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111072
- Sponsor's protocol ID
- 050155
- Other IDs
- 05-D-0155
- Status last verified
- Mar 2006
- First submitted
- 16 May 2005
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Axell T, Rundquist L. Oral lichen planus--a demographic study. Community Dent Oral Epidemiol. 1987 Feb;15(1):52-6. doi: 10.1111/j.1600-0528.1987.tb00480.x.
PubMed 3467894Eisen D. The clinical manifestations and treatment of oral lichen planus. Dermatol Clin. 2003 Jan;21(1):79-89. doi: 10.1016/s0733-8635(02)00067-0.
PubMed 12622270Scully C, Beyli M, Ferreiro MC, Ficarra G, Gill Y, Griffiths M, Holmstrup P, Mutlu S, Porter S, Wray D. Update on oral lichen planus: etiopathogenesis and management. Crit Rev Oral Biol Med. 1998;9(1):86-122. doi: 10.1177/10454411980090010501.
PubMed 9488249
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone 0.01% Solution for the Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT00111072
- Acronym / sponsor ID
- 050155
- Conditions
- Oral Lichen Planus
- Keywords
- Mucosal Disease, Topical Steroids, Salivary Diagnostics, Oral Pain, Quality of Life Indicators, Oral Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- May 2005
- Study completion
- Mar 2006
- First posted
- 16 May 2005 (estimated)
- 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.
This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain associated with oral lichen planus, a chronic disease that causes painful ulcers inside the mouth. The cause of lichen planus not known, but it may be related to an allergic or immune reaction. This study will examine what causes the disease, the pain associated with it, its impact on patients' lives and the use of dexamethasone to treat it.
Patients 12 or older with severe oral lichen planus may be eligible for this study. Candidates are screened with blood tests and a biopsy to confirm the diagnosis and provide tissues for research purposes. For the biopsy, two small circles of tissue, each about 4 mm (1/5 inch) across, are surgically removed.
Participants are randomly assigned to rinse their mouth with either a dexamethasone solution or placebo (a rinse with no active ingredient) four times a day for 4 weeks. During this period they may not use any oral or topical pain or anti-inflammatory medications except diphenhydramine 12.5 mg/5 ml (a topical numbing medicine) and Tylenol, both which are provided by the study.
Patients come to the NIH Clinical Center for three 1-hour visits (once every two weeks) and once more 4 weeks after the study medications are stopped. At the first three visits patients submit a pain diary in which they have recorded information on pain levels, and they are checked for any medication side effects. On the third visit (the last day they take the study drug) they are also tested for adrenal suppression that may have resulted from taking the steroid rinse. For this test they are given an injection of a drug called synacthen and after 1 hour, a blood sample is drawn. Patients return for a final visit 1 month later to determine if their disease returns or improves after the medication is stopped.
Detailed description
This is a study of pain, oral function and salivary biomarkers in oral lichen planus.
The primary objective of the study is to determine the efficacy of dexamethasone rinse in reducing pain in patients with oral lichen planus. Secondary objectives are to evaluate a novel scoring system of severity of lichen planus, assess the changes in salivary biomarkers associated with the treatment, assess the impact of oral lichen planus on the quality of life using the SF-36 instrument and the Oral Health Impact Profile (OHIP-14).
This is a double-blind parallel group design with 20 patients in each arm. Our primary outcome measure will be change in the visual analog scale that assesses pain. We will consider a decrease of 30 mm as clinically significant. Secondary outcomes will include reduction of oral symptoms as measured by the OHIP-14, amount of topical analgesic used, improvement in quality of life scores, and the severity of lesions as assessed with two scales.
A new oral lichen planus scoring system will be evaluated for validity, reliability and sensitivity to change. This system will quantify the severity and amount of oral lichen planus lesions on a scale of 0 to 66. Validation of this scale is needed for future studies of oral lichen planus. The validity and sensitivity to change will be assessed by correlation of the scores with patient based outcomes as well as global scale. Inter- and intra-rater reliability will also be tested.
The principal study interventions will be dexamethasone 0.01% oral rinse or identical in appearance and taste placebo rinse. Additional allowed interventions will be standard oral topical analgesic rinse and acetaminophen on an as needed basis. Diagnostic and research evaluations will include complete history and oral and general physical examination, laboratory investigations, saliva collection, and oral mucosal biopsy. The interventional period of the trial will be 4 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy confirmed symptomatic oral lichen planus. World Health Organization histological criteria (12) in combination with a compatible clinical appearance will be used for diagnosis.
- No current treatment with immunomodulatory agents. A one-month washout period will be required prior to enrollment if patients are taking immunomodulatory agents. Prior treatment with topical steroids will be allowed provided the presence of symptomatic lesions.
- Age greater than 12 years old. Lichen planus is very rare in patients younger than 40 years old. Patients must rinse and spit the medication rather than swallow it. Oral rinses such as topical fluorides are not recommended for young children.
- Patients of both sexes and all racial and ethnic groups will be eligible.
- Symptomatic lichen planus with a score of at least 35 mm on a visual analog scale for pain.
Key exclusion criteria (8 listed)
- Unable to undergo oral biopsy for diagnosis.
- Asymptomatic lichen planus with no ulcerated or erythematous oral lesions.
- Treatment with immunomodulatory agents within 1 month of the randomization.
- Hepatitis C infection.
- Documented hypersensitivity to dexamethasone.
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 |
|---|---|---|
| dexamethasone 0.01% solution | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3467894Axell T, Rundquist L. Oral lichen planus--a demographic study. Community Dent Oral Epidemiol. 1987 Feb;15(1):52-6. doi: 10.1111/j.1600-0528.1987.tb00480.x.
- Background: PubMed 12622270Eisen D. The clinical manifestations and treatment of oral lichen planus. Dermatol Clin. 2003 Jan;21(1):79-89. doi: 10.1016/s0733-8635(02)00067-0.
- Background: PubMed 9488249Scully C, Beyli M, Ferreiro MC, Ficarra G, Gill Y, Griffiths M, Holmstrup P, Mutlu S, Porter S, Wray D. Update on oral lichen planus: etiopathogenesis and management. Crit Rev Oral Biol Med. 1998;9(1):86-122. doi: 10.1177/10454411980090010501.
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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.
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 0.01% solution in people with Oral Lichen Planus, run by National Institute of Dental and Craniofacial Research (NIDCR) 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 6 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: finished, as of the sponsor's last update on 4 Mar 2008. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00111072, which also lists 3 linked publications.
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 4 Mar 2008.