Oral Lichen PlanusPhase 2NCT00226174
A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus
A Phase 2 study testing Curcuminoids in people with Oral Lichen Planus, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Curcuminoids
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to the UCSF oral medicine clinic with oral lichen planus confirmed by biopsy. Patients with either the atrophic or the erosive form of oral lichen planus were eligible.
- Study subjects had to have a symptom score between 3 to 8 at the time of entry into the study. (Range of scale: zero to ten, with zero being no symptoms and ten being the worst imaginable symptoms.)
- Eligible subjects had to have discontinued systemic and/or topical corticosteroids for at least two weeks before entry into the study.
Who cannot join
- Pregnancy, lactation or unwillingness to use an effective method of contraception. An attempt was to be made to ascertain the date of the last menstrual period among eligible pre-menopausal women. If pregnancy could not be ruled out, a pregnancy test was to be provided to the women before enrollment into the study.
- Patients younger than 21 years of age.
- Patients who could not return for follow-up visits at one week, 4 weeks and 7 weeks after enrollment.
- Patients with a medical contraindication or refusal to take prednisone and or/fluconazole.
- Patients who had a medical contraindication to discontinuation of systemic corticosteroids (eg. those on long term corticosteroid therapy).
- Patients with a history of gastric / duodenal ulcers or gallstones.
Show all 9Show fewer
- Patients with a history of liver disease.
- Patients on anticoagulants or antiplatelet medications.
- Patients undergoing orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94143
About this study
The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.
Read the detailed description
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.
- Conditions
- Oral Lichen Planus
- Being tested
- Curcuminoids
- Keywords
- Curcuminoids, Oral Lichen Planus
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminoidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom scores at 7 weeks
Secondary outcomes (2)
Change in clinical signs at one, four and seven weeks
Change in symptom scores at one and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Nita Chainani-Wu, DMD, MPH, MS, Principal investigator, Assistant Clinical Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226174
- Sponsor's protocol ID
- H1113-19156-03
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2005
- Last updated
- 8 Nov 2023
- Results posted
- No
Publications
Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
PubMed 12676044Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Lozada-Nur F, Weintraub J. Validation of instruments to measure the symptoms and signs of oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jan;105(1):51-8. doi: 10.1016/j.tripleo.2007.06.022.
PubMed 18155609
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT00226174
- Acronym / sponsor ID
- H1113-19156-03
- Conditions
- Oral Lichen Planus
- Keywords
- Curcuminoids, Oral Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2003
- Study completion
- Sep 2004
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting to the UCSF oral medicine clinic with oral lichen planus confirmed by biopsy. Patients with either the atrophic or the erosive form of oral lichen planus were eligible.
- Study subjects had to have a symptom score between 3 to 8 at the time of entry into the study. (Range of scale: zero to ten, with zero being no symptoms and ten being the worst imaginable symptoms.)
- Eligible subjects had to have discontinued systemic and/or topical corticosteroids for at least two weeks before entry into the study.
Key exclusion criteria (9 listed)
- Pregnancy, lactation or unwillingness to use an effective method of contraception. An attempt was to be made to ascertain the date of the last menstrual period among eligible pre-menopausal women. If pregnancy could not be ruled out, a pregnancy test was to be provided to the women before enrollment into the study.
- Patients younger than 21 years of age.
- Patients who could not return for follow-up visits at one week, 4 weeks and 7 weeks after enrollment.
- Patients with a medical contraindication or refusal to take prednisone and or/fluconazole.
- Patients who had a medical contraindication to discontinuation of systemic corticosteroids (eg. those on long term corticosteroid therapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcuminoids | Drug | – |
Primary outcome
Change in symptom scores at 7 weeks
2 secondary outcomes
Change in clinical signs at one, four and seven weeks
Change in symptom scores at one and four weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 12676044Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
- Derived from this study: PubMed 18155609Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Lozada-Nur F, Weintraub J. Validation of instruments to measure the symptoms and signs of oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Jan;105(1):51-8. doi: 10.1016/j.tripleo.2007.06.022.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nita Chainani-Wu, DMD, MPH, MS principal investigator
Assistant Clinical Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcuminoids in people with Oral Lichen Planus, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom scores at 7 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.