Dexamethasone to Treat Oral Lichen Planus

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00111072
First received: May 16, 2005
Last updated: March 3, 2008
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Oral Lichen Planus
Drug: dexamethasone 0.01% solution
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Dexamethasone 0.01% Solution for the Treatment of Oral Lichen Planus

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 70
Study Start Date: May 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111072

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00111072     History of Changes
Other Study ID Numbers: 050155, 05-D-0155
Study First Received: May 16, 2005
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mucosal Disease
Topical Steroids
Salivary Diagnostics
Oral Pain
Quality of Life Indicators
Oral Lichen Planus

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014