Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111072
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-05-16
Brief Title:
Dexamethasone to Treat Oral Lichen Planus
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dexamethasone 001 Solution for the Treatment of Oral Lichen Planus
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of dexamethasone 001 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 15 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 125 mg5 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
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 15 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 125 mg5 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 001 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
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 001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-D-0155 | None | None | None |