Dexamethasone to Treat Oral Lichen Planus

NCT00111072 | Completed Phase 2

• 2 other identifiers: 05015505-D-0155
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Lichen Planus

Keywords

Mucosal Disease; Topical Steroids; Salivary Diagnostics; Oral Pain; Quality of Life Indicators; Oral Lichen Planus

Interventions

dexamethasone 0.01% solution DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 3467894 BACKGROUND

• Eisen 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.

  PMID: 12622270 BACKGROUND

• Scully 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.

  PMID: 9488249 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Dexamethasone; Solutions

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 16, 2005
• First Posted: May 16, 2005
• Study Start: May 1, 2005
• Study Completion: March 1, 2006
• Last Updated: March 4, 2008

Record last verified: 2006-03

Locations

US (1)