Oral Lichen Planus Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blind Trial of a Two Week Course of Curcuminoids in Oral Lichen Planus
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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