Clinical Trials Logo

Clinical Trial Summary

A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized to receive either placebo or curcuminoids 6000mg/day for 2 weeks in three divided doses of 2000mg three times/day. Measurement of signs, symptoms, periodontal status and blood tests including complete blood count, liver enzymes, serum c reactive protein and serum interleukin-6 levels will be done at baseline and at the end of 2 weeks. A side-effects questionnaire will be administered at the 2-week follow-up.

The Numeric Rating Scale (NRS) will be used to measure symptoms and the Modified Oral Mucositis Index (MOMI) to measure clinical signs of OLP. Primary outcome is change in symptoms from baseline. Secondary outcomes are change in clinical signs, occurrence of side-effects, change in serum C-reactive protein and serum interleukin-6 levels.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00525421
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date October 2007
Completion date February 2009

See also
  Status Clinical Trial Phase
Recruiting NCT05997173 - The Regulatory Role of Immune Response in Oral Lichen Planus
Completed NCT02443311 - Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus Phase 4
Completed NCT00484250 - Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other Phase 2
Completed NCT03682562 - Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions
Not yet recruiting NCT06428630 - Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus Early Phase 1
Completed NCT04193748 - Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial) Phase 4
Completed NCT04153266 - Oral Epithelial Dysplasia Informational Needs Questionnaire
Recruiting NCT06135805 - Impact of Fluocinonide 0,05% in Oral Lichen Planus N/A
Completed NCT04289233 - Molecular & Cellular Characterisation of Oral Lichen Planus
Completed NCT04293718 - Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy
Not yet recruiting NCT04091698 - Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial Phase 1
Completed NCT03386643 - Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus Phase 2
Withdrawn NCT03836885 - Apremilast - Oral Lichen Planus Trial Phase 2
Completed NCT05730855 - Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions
Completed NCT03257228 - The Association Between Diabetes Mellitus, Oral Lichen Planus and Insulin-like Growth Factors 1 and 2 (IGF1 and IGF2) N/A
Recruiting NCT03026478 - Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus Phase 2
Completed NCT02834520 - Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus N/A
Completed NCT02858297 - Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus Phase 4
Completed NCT02106468 - The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus Phase 2
Recruiting NCT00737854 - Free Soft Tissue Graft in Treatment of Oral Lichen Planus Phase 1