Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus
Status:
Completed
Trial end date:
2005-10-01
Target enrollment:
Participant gender:
Summary
This study will compare two treatments for oral lichen planus - hydroxychloroquine
(Plaquenil) tablets and clobetasol oral rinse. Oral lichen planus is a chronic disorder in
which patients have painful mouth ulcers that interfere with meals and daily functioning. It
is most commonly treated with topical or systemic corticosteroids, but these drugs have a
number of side effects, most commonly yeast infection, and chronic systemic use of them can
lead to diabetes, osteoporosis, weight gain, and other complications. Also, lichen planus
generally returns when the corticosteroids are stopped. Clobetasol oral rinse is a topical
steroid commonly used to treat oral lichen planus. Hydroxychloroquine, a drug that was
originally used to treat malaria and is now also approved for lupus and rheumatoid arthritis,
has been tried for lichen planus in small-scale studies with some evidence of benefit.
Patients 18 years of age and older with oral lichen planus may be eligible for this study.
Pregnant women are excluded. Candidates are screened with a dermatology examination, routine
blood tests, an eye examination, and a biopsy to rule out other conditions similar to lichen
planus and to provide tissue for research purposes. For the biopsy, two small circles of
tissue about 4 mm (less than 1/5") across are surgically removed from the area with lichen
planus.
Participants are randomly assigned to treatment with either hydroxychloroquine or clobetasol
rinse. Patients assigned to hydroxychloroquine also take a placebo mouth rinse that looks and
tastes like the clobetasol rinse, and those assigned to clobetasol also take a pill that
looks and tastes like the hydroxychloroquine tablet. This is done so that neither the
patients nor the study doctors know which patient is taking which active medication until the
study is completed. Patients take the pills daily in the morning with food or a glass of milk
for the 6-month study period and use the rinse twice a day for 4 months and then once a day
for 2 months. They may not use any pain or anti-inflammatory medicines or topical creams,
gels or rinses regularly, because these medications can obscure the effects of the study
drugs and complicate interpretation of the results. They are given a topical numbing medicine
as part of the study and can use Tylenol for pain during the study duration.
In addition to treatment, participants visit the NIH Clinical Center once a month for the
following tests and procedures:
- Review of pain levels, as recorded in a pain diary
- Review of drug side effects, if any
- Collection of saliva and blood samples at 2, 4 and 6 months
- Repeat oral biopsy at completion of the study at 6 months to evaluate treatment effects
- Final examination at 8 months to determine if the disease returns or improves after the
medication is stopped.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)