Trial of Antimycobacterial Therapy in Sarcoidosis

Inclusion Criteria

• •1. Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as defined by the clinical presentation consistent with sarcoidosis, biopsy finding granulomas, and no alternative for the cause of the granulomas, such as tuberculosis
• •2. Patients must have chronic cutaneous skin lesions with or without taking chronic therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine, hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in which the dose has not been altered in the 2 months prior to starting the study.
• •3. Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a Sarcoidosis Activity and Severity Index assessment score of at least 4. Diagnosis can be made by either:
• •* Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with no evidence of mycobacteria, fungus, or malignancy.
• •* A biopsy that does not show granulomas, but the patient has characteristic skin lesions and history of clinical features suggesting sarcoidosis (previous biopsy revealing noncaseating granuloma, bilateral hilar adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis (CD4:CD8\>3.5), panda/lambda sign on gallium scan)
• •* Accepted clinical variants include, but are not necessarily limited to the following:
• •* lupus pernio
• •* nodular
• •* subcutaneous
• •* annular
• •* angiolupoid
• •* plaque
• •* papular
• •* lichenoid
• •* psoriasiform
• •* For purposes of this study "moderate to severe cutaneous sarcoidosis" is defined as the presence of sarcoidal skin lesions with any of the following features:
• •* At least 5 easily visible facial lesions, or
• •* Disease which involves \> 3% BSA, or
• •* Disease which confers functional impairment (e.g. nasal or visual field obstruction), or
• •* Disease which confers significant symptoms of itching and/or pain.
• •4. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is using one of the following methods of birth control for the duration of the study and 90 days after study completion:
• •* condoms, sponge, foams, jellies, diaphragm, or intrauterine device
• •* contraceptives (oral or parenteral) for three months prior to study drug administration
• •* a vasectomized sole partner
• •* Females of childbearing potential must have a negative serum pregnancy test at screening visit.