Clinical trial: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus (NCT00226174)

Eligibility criteria:
Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Contradiction