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Sponsors and Collaborators: |
University of California, San Francisco National Institutes of Health (NIH) |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00226174 |
The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.
Condition | Intervention | Phase |
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Oral Lichen Planus |
Drug: Curcuminoids |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | September 2004 |
Lichen planus is a chronic mucocutaneous, immunologic disease. It can affect the oral mucosa, causing changes that can range from white lace-like patterns on the mucosa, to red atrophic changes to the presence of ulcerations. Symptoms can range from none to severe soreness that greatly interferes with eating. The etiology of lichen planus is not known, and because the tissue damage is mediated by immune cells, lichen planus is considered to be an autoimmune disease. Currently, the most common treatment for oral lichen planus (OLP) is use of systemic and/or topical steroids. These medications though efficacious have side-effects that limit the effectiveness of these treatments. Tumeric, which comes from the plant curcuma longa, has been used for centuries in Ayurveda (Indian traditional medicine) for its anti-inflammatory properties. In western scientific studies, including invitro studies, animal studies and human studies, components of tumeric called curcuminoids (which include, curcumin (diferuloyl methane), demethoxycurcumin, and bisdemethoxycurcumin) have been found to have anti-inflammatory properties and to be very safe, with few side-effects even at high doses. The objective of this study is to determine whether curcuminoids, which are safe, non-toxic compounds, can be used to control the signs and symptoms of OLP, a disease which can have serious morbidity, and for which current treatment has significant side-effects. If found to be efficacious, these tumeric extracts will aid patients with OLP in reducing symptoms and therefore the morbidity associated with OLP.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Nita Chainani-Wu, DMD, MPH, MS | Assistant Clinical Professor |
Study ID Numbers: | H1113-19156-03 |
Study First Received: | September 22, 2005 |
Last Updated: | September 22, 2005 |
ClinicalTrials.gov Identifier: | NCT00226174 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Curcuminoids Oral Lichen Planus |
Mouth Diseases Lichen Planus Exanthema Skin Diseases |
Stomatognathic Diseases Oral Lichen Planus Skin Diseases, Papulosquamous Lichen Planus, Oral |
Mouth Diseases Lichen Planus Skin Diseases Stomatognathic Diseases |
Lichenoid Eruptions Skin Diseases, Papulosquamous Lichen Planus, Oral |