A Randomized, Placebo-controlled, Double-blind Clinical Trial of Curcuminoids in Oral Lichen Planus

NCT00226174 | Terminated Phase 2

• 1 other identifier: H1113-19156-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether curcuminoids are effective in the treatment of oral lichen planus.

Conditions

Oral Lichen Planus

Keywords

Curcuminoids; Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Curcuminoids DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with a history of liver disease.
• Patients on anticoagulants or antiplatelet medications.
• Patients undergoing orthodontic treatment.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

Related Publications (2)

• 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.

  PMID: 12676044 BACKGROUND

• Chainani-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.

  PMID: 18155609 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Diarylheptanoids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Nita Chainani-Wu, DMD, MPH, MS

  Assistant Clinical Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: February 1, 2003
• Study Completion: September 1, 2004
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

US (1)