Clinical trial: Hydroxychloroquine vs. Clobetasol Rinse to Treat Oral Lichen Planus (NCT00102557)

Eligibility criteria:
INCLUSION CRITERIA:

        Biopsy confirmed symptomatic erosive oral lichen planus. World Health Organization
        histological criteria (21) in combination with compatible clinical picture will be used for
        diagnosis. In questionable cases, direct immunofluorescence will be performed to exclude
        other conditions.

        No current treatment with hydroxychloroquine or other immunomodulatory agents. A one-month
        washout period will be required prior to enrollment if patients are taking immunomodulatory
        agents. Prior treatment with topical steroids will be allowed.

        Age greater than 18 years old. Lichen planus is very rare in patients younger than 40 years
        old and children are especially sensitive to the effects of hydroxychloroquine.

        Patients of both sexes and all racial and ethnic groups will be eligible.

        The presence of at least one ulcerated oral lesion with a surface area of at least 100 sq.
        mm as measured bi-directionally.

        EXCLUSION CRITERIA:

        Unable to undergo oral biopsy for diagnosis

        Lichen planus with no ulcerated oral lesions of greater than 100 sq. mm in area.

        Treatment with hydroxychloroquine or other immunomodulatory agents within 1 month of the
        randomization.

        Hepatitis B or Hepatitis C infection

        Significant abnormalities in hepatic status as measured by liver function tests (ALT, AST,
        AP, bilirubin.) Mild asymptomatic elevations in liver enzymes (up to 20% above the
        reference range) will not preclude enrollment in the trial.

        Significant abnormalities in renal status as measured by kidney function tests (creatinine,
        BUN).

        Uncontrolled diabetes

        Contraindications to hydroxychloroquine or clobetasol therapy (known hypersensitivity,
        retinopathy from prior use, history of aplastic anemia or agranulocytosis).

        Anemia (defined as a hemoglobin level more than 2 standard deviations below the mean
        reference value for age).

        Granulocytopenia (defined as an absolute neutrophil count (ANC) in adults as less than
        1500/mm(3)).

        Pregnancy or lactation. Pregnancy status will be assessed by questionnaire. Potentially
        pregnant patients will be evaluated by plasma HCG test. Patients planning pregnancy will be
        excluded. Sexually active females will be required to use contraception prior to enrollment
        in the study. Every woman of childbearing age will have a pregnancy test.

        Inability or unwillingness to give written informed consent.

        Serious concurrent disease (e.g. myocardial infarction, severe heart failure, severe COPD)
        requiring hospitalization or limiting life expectancy to less than 1 year.

        Psoriasis

        G6PD deficiency

        Porphyria

        Chronic use of non-steroidal anti-inflammatory agents or other agents to relieve pain.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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